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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12625000695404
Ethics application status
Approved
Date submitted
6/05/2025
Date registered
1/07/2025
Date last updated
1/07/2025
Date data sharing statement initially provided
1/07/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Sub-Protocol #3 of Umbrella Protocol Study: Characterization of the Limit of Blank (LoB) for Vancomycin Biosensors on the Nutromics Sensor Device: Optimizing Microneedle Lengths.
To assess the impacts of microneedle depth on the Limit of Blank (LoB) of the Nutromics Sensor Device
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Scientific title
Sub-Protocol #3 of Umbrella Protocol Study: Characterization of the Limit of Blank (LoB) for Vancomycin Biosensors on the Nutromics Sensor Device: Optimizing Microneedle Lengths.
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Secondary ID [1]
314376
0
NCRC-AU-2024/003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
Sub-protocol#3 is part of the umbrella protocol that is connected with sub-protocol #1 (ACTRN12625000115437) and sub-protocol#2 (ACTRN12625000125426). Each sub-protocol investigates a particular condition(s) in which challenges various Vancomycin biosensors and electrode properties of the Nutromics sensor device.
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Health condition
Health condition(s) or problem(s) studied:
Therapeutic Drug Monitoring
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Condition category
Condition code
Infection
333755
333755
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This is a prospective study with an Umbrella Protocol; where each sub-Protocol investigates a particular condition(s) and challenges to various Vancomycin biosensors and electrode properties. The study will enroll healthy participants in the community. Participants will be recruited for participation in stages depending on the Research and Development needs. This is a multi-stage sub protocol, evaluating several different depths of the microneedles as well as the impact of an isolation layer on the electrodes on the Nutromics Sensor Devices across the different stages. 10 participants will be enrolled per stage. Stages may run in parallel. Participants will be recruited and enrolled as needed. They will not be randomised or stratified into specific groups but will participate in stages as required for the research and development of the Nutromics Sensor Device. Stage 1 will assess the LoB of the Nutromics Sensor Devices when participants conduct their normal daily activities., Stage 2 will assess the LoB of the Nutromics Sensor Devices when participants perform several physical activities.
The study will enroll no more than 50 participants. Participants may participate in more than one sub-Protocol of the Study, subject to their continued eligibility.
Potential participants will be recruited by flyers on community, university, and
Nutromics Operations noticeboards. Prospective participants will express interest via email to
[email protected]
.
Participants who have previously participated or expressed interested in studies at the Nutromics Clinical Research Centre may also be contacted and asked if they are interested in participating. Prospective participants will be sent an Online Health Screening. Nutromics employees can participate in this study.
Participants who meet the inclusion criteria (as per the Online Health Screening Survey) will be contacted for a brief phone screening for inclusion/exclusion criteria, including an explanation of the study details. A copy of the patient information sheet and consent form will be given to the participants who meet the inclusion criteria and still express interest in participating in the study following the phone discussion. Eligible participants who agree to participate in the study will be given time to consider their decision. Eligible participants who agree to participate in the study will be asked to attend an on-site Visit, where written consent will be obtained before any study procedures are conducted.
All on-site visits, and the procedures outlined below will be performed by the Clinical Research Coordinator (research nurse).
Sub-Protocol #3 Synopsis:
To assess the impact of microneedle depth on the Limit of Blank (LoB) of the Nutromics Sensor Device.
Participants will arrive on-site and have six Nutromics Sensor Devices applied to either upper arm consisting of up to three different configurations. At least 1 set will have 5mm microneedles on the Nutromics Sensor Device with an isolation layer on the needle electrodes. Another set with have 3 mm needle electrodes with an isolation layer, and the last set will have either 3 or 5 mm needle electrodes without an isolation layer (this decision will be based on in-vitro data and previous interim analysis from testing both 3mm and 5mm sets and deciding which set provides the best limit of blank results). The participants will return to the study site the following day (i.e. 24 hours later), where the Devices will be removed.
The schedule of events is outlined below.
Stage 1: On Site Visit
1. Written informed consent will be obtained
Participants without childbearing potential will progress straight to Step #3
2. A pregnancy test will be conducted in all participants with childbearing potential
3. Pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected immediately prior to application of Nutromics Sensor Devices.
4. Image of the Device application sites will be taken.
5. Application of six Nutromics Sensor Devices on the upper arm area following blood collection (+15 min).
6. Participants will complete an assessment post application (+15 min) of Nutromics Sensor Devices to assess the pain associated with application of the devices.
7. Participants will remain at the site for 1 hour (+15 min) post application of Nutromics Sensor Devices
8. Immediately prior to the participant leaving the site, pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected, and participants will complete an assessment post application (+15 min) of Nutromics Sensor Devices to assess the pain associated with application of the devices.
9. Participants may perform their normal daily activities including sports, showering, etc.; and the type of activity, start and end time of these activities shall be recorded by the participant. The Devices should not be submerged in water.
10. Participants will be instructed to avoid apply excessive force or pressure on the Nutromics Sensor Devices.
11. In the event the Nutromics Sensor Device(s) fall off, participants are instructed not re-apply the device.
12. Participants will return to the site between 22 - 24 hours post Nutromics Sensor Device application,
13. Immediately prior to the removal of the Nutromics Sensor Devices, pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected (-15 min)
14. The Nutromics Sensor Devices are removed
15. Images are taken of the application sites for each of the Nutromics Sensor Device following their removal. Care will be taken to avoid identifiable features.
16. The participant is observed for 15 minutes (+15 min) following removal of the Nutromics Sensor Devices, after which they are discharged from the study.
Participants will be asked to report (using an online system) any adverse events
Stage 2:
Participants will arrive on-site and have six Nutromics Sensor Devices applied to either upper arm consisting of up to three different configurations. At least one set of Nutromics Sensor Devices will have 5mm microneedles with an isolation layer, another set with have 3 mm needles with an isolation layer, and the last set will have either 3 or 5 mm needles without an isolation layer (this decision will be based on in-vitro data and previous interim analysis collected from testing both 3mm and 5mm sets and deciding which set provide the best limit of blank results). After completing all study visits procedures, participants will be allowed to leave the study site with the devices on their arm. Participants will return to the study site the following day (i.e. 24 hours later), where the Devices will be removed.
On Site Visit
1. Written informed consent will be obtained
Participants without childbearing potential will progress straight to Step #3
2. A pregnancy test will be conducted in all participants with childbearing potential
3. Pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected immediately prior to application of Nutromics Sensor Devices.
4. Image of the Device application sites will be taken.
5. Application of six Nutromics Sensor Devices on the same upper arm following blood collection (+15 min).
6. Participants will complete an assessment post application (+15 min) of Nutromics Sensor Devices to assess the pain, and mobility impact associated with application of the devices.
7. Following the pain assessment, participants will be weighed wearing minimal clothing, such as a sports bra and shorts, or a gown. No shoes to be worn. Any water to be consumed during the study should also be held during weighing.
8. Participant will remain seated at rest for 1.5 hours (+5 min)
8.1: A member of the study team will apply pressure to one set of the Nutromics Sensor Devices for 60 seconds (i.e.: push the Device firmly onto the skin). Participants will complete an assessment post application (+15 min) of Nutromics Sensor Devices to assess the pain and mobility impact associated with pressure application.
8.2: A member of the study team will apply pressure to another set of the Nutromics Sensor Devices for 60 seconds (i.e.: push the Device firmly onto the skin), 10 minutes after applying pressure to the first set. Participants will complete an assessment post application (+15 min) of Nutromics Sensor Devices to assess the pain and mobility impact associated with pressure application.
8.3: A member of the study team will apply pressure to another set of the Nutromics Sensor Devices for 60 seconds (i.e.: push the Device firmly onto the skin), 10 minutes after applying pressure to the second set. Participants will complete an assessment post application (+15 min) of Nutromics Sensor Devices to assess the pain and mobility impact associated with pressure application.
9. Immediately proceeding completion of #8, participant will walk at steady speed on treadmill for 30 minutes (+5 min) (Rate of Perceived Exertion (RPE) 2-3)
10. Immediately proceeding #9, participant will jog on treadmill for 30 minutes (RPE 7-8)
11. Immediately proceeding #10, participant will remain seated at rest for 30 minutes (+5 min)
12. Immediately proceeding #11, participants will be reweighed wearing minimal clothing, same clothing as worn in Step #5.
13. Immediately prior to the participant leaving the site, pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected, and participants will complete an assessment post application (+15 min) of Nutromics Sensor Devices to assess the pain associated with application of the devices.
14. Participants may perform their normal daily activities including sports, showering, etc.; and the type of activity, start and end time of these activities shall be recorded by the participant. The Devices should not be submerged in water.
15. Participants will be instructed to avoid apply excessive force or pressure on the Nutromics Sensor Devices.
16. In the event the Nutromics Sensor Device(s) fall off, participants are instructed not re-apply the device.
17. Participants will return to the site between 22 - 24 hours post Nutromics Sensor Device application,
18. Immediately prior to the removal of the Nutromics Sensor Devices, pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected (-15 min)
19. The Nutromics Sensor Devices are removed
20. Images are taken of the application sites for each of the Nutromics Sensor Device following their removal. Care will be taken to avoid identifiable features.
21. The participant is observed for 15 minutes (+15 min) following removal of the Nutromics Sensor Devices, after which they are discharged from the study.
22. Participants will be asked to report (using an online system) any adverse events
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Intervention code [1]
331130
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Early Detection / Screening
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Comparator / control treatment
NO control group.
Within the set, each device may be the same or different in configuration.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Establish the highest reported concentration Limit of Blank (LoB) likely to be observed for a blank sample using the Nutromics Sensor Device.
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Assessment method [1]
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In-vivo data collection will be calibrated against a standard titration of known values on analogous devices to report concentrations. The workflow to achieve this involves benchtop testing of Nutromics aptamer sensors in buffer and/or biofluid with a known concentration of vancomcyin across a range of temperatures anticipated in-vivo (30-42C). Addition of known values of vancomycin and subsequent measurements. Fitting a calibration equation, and finally using data collected from the device (electrochemical measurements & temperature measurements) in this equation to predict concentration. Limit of Blank will be reported using the predicted mean concentration + 2 standard deviations for a given device’s data ( during the first and last hour of data collection.
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Timepoint [1]
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24 hour wear period.
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Primary outcome [2]
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To assess the impact of microneedle depth on the Limit of Blank (LoB) of the Nutromics Sensor Device
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Assessment method [2]
341339
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The accuracy of the device from interstitial fluid measurements with different configurations will be assessed as the deviation of vancomycin concentrations from 0 mg/L. The precision will be assessed as the variability (standard deviation) of vancomycin concentrations (if detected) across devices and across participants. This data will be evaluated as a composite outcome. Signal to noise will be calculated from voltammogram data using the root-mean-squared error (RSME) of the raw signal versus the smoothed (Savitzky-Golay) data
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Timepoint [2]
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24 hour wear period.
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Secondary outcome [1]
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Evaluate the variability and error associated with Vancomycin biosensors when the target analyte is not present.
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Assessment method [1]
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The accuracy of the device from interstitial fluid measurements will be assessed as the deviation of vancomycin concentrations from 0 mg/L. The precision will be assessed as the variability (standard deviation) of vancomycin concentrations (if detected) across devices and across participants. This data will be evaluated as a composite outcome. Signal to noise will be calculated from voltammogram data using the root-mean-squared error (RSME) of the raw signal versus the smoothed (Savitzky-Golay) data.
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Timepoint [1]
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Across wear period where the Nutromics Sensor Device will collect data on vancomycin concentrations in interstitial fluid every 5 minutes.
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Secondary outcome [2]
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To evaluate the safety of the Nutromics sensor device.
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Assessment method [2]
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Monitoring full blood count (FBC), urea electrolytes creatinine (UEC), and liver function test (LFT) results and C-reactive Protein (CRP), prior to the application, and following removal of the Investigational Device. Examining digitally captured images of the skin surface at the sensor application site(s) for signs of irritation and allergic reactions. Observing participants pain using the scales provided (Harvard pain Scale). Assess adverse events using the MedDRA class system.
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Timepoint [2]
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Blood will be collected at three occasions to assess safety of the Nutromics Sensor Device; immediately prior to application of the Devices, immediately prior to the participant being discharged whilst wearing the Device, and immediately following the removal of the Device the following day. Images of the application site will be taken prior to the application and removal of the Device. A pain score is obtained from the participant no more than 15 minutes following application of each Nutromics Sensor Device. Adverse Events will be assessed across the wear time of the Device.
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Secondary outcome [3]
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Characterise the impact of hydration on the LoB of Vancomycin biosensors (serum osmolality)
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Assessment method [3]
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Blood will be tested for serum osmolality.
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Timepoint [3]
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Blood will be collected at three occasions to assess serum osmolality; immediately prior to application of the Devices, immediately prior to the participant being discharged whilst wearing the Device, and immediately following the removal of the Device the following day,
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Secondary outcome [4]
447170
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To assess the effects of an insulating layer on the electrodes on the Limit of Blank (LoB) of the Nutromics Sensor Device
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Assessment method [4]
447170
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The accuracy of the device from interstitial fluid measurements with different configurations will be assessed as the deviation of vancomycin concentrations from 0 mg/L. The precision will be assessed as the variability (standard deviation) of vancomycin concentrations (if detected) across devices and across participants. This data will be evaluated as a composite outcome. Signal to noise will be calculated from voltammogram data using the root-mean-squared error (RSME) of the raw signal versus the smoothed (Savitzky-Golay) data
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Timepoint [4]
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24 hour wear period.
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Eligibility
Key inclusion criteria
Participants self-declaring healthy without any disease, condition or syndrome or on any current prescription medical treatments (other than contraception medication)
(Stage 2 only): Participants are comfortable (self-reported) to walk and jog, each for up to 30 minutes.
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Participants who are pregnant, lactating, planning to become pregnant, breastfeeding, or donating ova.
Participants who declare previous allergic reactions to metals, plastics, and adhesives.
Participants who have a history of fainting or experiencing vasovagal reactions during blood draws.
Non-English-speaking participants.
Participants with small children in their household, where the Investigator believes that the device falling off could pose a biohazard risk if a child were to pick it up
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
7/07/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Nutromics Operations Pty Ltd
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Address [1]
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Country [1]
318894
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Nutromics Operations Pty Ltd
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
321358
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Country [1]
321358
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Nutromics Diagnostics HREC
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Ethics committee address [1]
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https://www.nd-hrec.org/researchers
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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20/06/2025
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Approval date [1]
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24/06/2025
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Ethics approval number [1]
317510
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Summary
Brief summary
This is a prospective study with an Umbrella Protocol, where each sub-Protocol investigates a particular condition(s) and challenges to various Vancomycin biosensors and electrode properties. The study will enrol up to 50 healthy participants in the community. The Sub-Protocol described in this registration form is Sub-Protocol #3: Characterization of the Limit of Blank (LoB) for Vancomycin Biosensors on the Nutromics Sensor Device: Optimizing Microneedle Lengths.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Sophie Stocker
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Address
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Rm No S303, Building No A15, The University of Sydney, NSW, 2006
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Country
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Australia
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Phone
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+61 427 490 796
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Sophie Stocker
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Address
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Rm No S303, Building No A15, The University of Sydney, NSW, 2006
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Country
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Australia
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Phone
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+61 427 490 796
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mark Friedel
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Address
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Nutromics; 420 Victoria Street, Brunswick ,3056, VIC, Australia
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Country
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Australia
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Phone
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+61432887350
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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