Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000760471
Ethics application status
Approved
Date submitted
21/05/2025
Date registered
17/07/2025
Date last updated
17/07/2025
Date data sharing statement initially provided
17/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility assessment of the ProtonPetals safety and performance in healthy human adults
Scientific title
Feasibility assessment of the ProtonPetal Alpha One device's safety and performance in healthy human adults
Secondary ID [1] 314467 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Potassium dysregulation (Hypokalemia) 337574 0
Potassium dysregulation (Hyperkalemia) 337576 0
Chronic Kidney Disease (CKD) 337575 0
Condition category
Condition code
Renal and Urogenital 333918 333918 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This investigational study will assess the ProtonPetal Alpha One device's ability to monitor interstitial potassium and other analytes in healthy adults. The ProtonPetal Alpha One is a wearable investigational device that uses a sensor inserted under the skin, designed for the continuous measurement of potassium levels in the subcutaneous Interstitial Fluid (ISF).

The study will be performed by an investigator that is a qualified general practitioner (GP) and an experienced clinical research nurse with over 5 years of experience. The study will be performed at a clinical site. Participants will be assessed for study inclusion, after which they will commence with the insertion of one peripheral intra-venous (IV) catheter, and three ProtonPetal Alpha One devices to the upper arm. All three ProtonPetal Alpha One devices will be applied to a single arm, and the catheter will be applied to the arm which does not contain any wearable devices.

The study will be performed only once per participant, over the course of a single 6 hour session, after which the investigational devices and catheters will be removed. Throughout this 6 hour period, blood samples will be taken from the IV catheter every 15 minutes to measure serum potassium levels which will be analyzed using clinically accepted point of care devices.
Intervention code [1] 331129 0
Treatment: Devices
Comparator / control treatment
The clinical reference methods to be used include two point of care devices;

1) The Abbott iSTAT, in conjunction with a CHEM8+ analyte cartridge to assess potassium levels
2) The Werfen GEM Premier 5000, blood gas testing system

Both PoC reference methods mentioned above are approved for assessment of blood analyte levels (inclusive of potassium), and thus will provide a high quality reference method for our study.

For both reference measurements, blood samples will be collected from each participant by a trained study nurse, The collected sample will then be applied to the iSTAT and GEM 5000 systems by trained personnel within 2-3 minutes of extraction, allowing for a time controlled, whole blood assessment of participant potassium levels.
Control group
Active

Outcomes
Primary outcome [1] 341566 0
To provide early feasibility data on the ProtonPetal Alpha One device function
Timepoint [1] 341566 0
Feasibility data generation will begin on the day of intervention, starting at the point of first ProtonPetal Alpha One device application. Following wearable device and catheter application, reference measurement blood draws (which will be used to generate feasibility data) will be taken every 15 minutes for 6 hours. Upon completion of the 6 hour wear period, the catheter and all wearable devices will be removed and no further device feasibility data will be collected.
Secondary outcome [1] 447948 0
To monitor the safety of the ProtonPetal Alpha One device, as characterized by adverse device effects
Timepoint [1] 447948 0
Safety data will be collected at all participant visits, starting from the point of participant enrolment (study visit 1), and the day of intervention (study visit 2). Safety data will also be collected up to the post-intervention phone call follow up 3 days after study visit 2. During the 3 day period post intervention, participants will have an open line of communication with the clinical nurse to document any adverse events which may arise during this period.
Secondary outcome [2] 447950 0
To assess the duration over which the ProtonPetal Alpha One device remains operational post-insertion (based on the change in voltage drift over the study period).
Timepoint [2] 447950 0
This will be assessed for a total of 6-hours from the point of investigational device application until device removal.
Secondary outcome [3] 447949 0
To characterise a composite of warmup time, signal drift and signal noise of the ProtonPetal Alpha One device using retrospective analysis methods.
Timepoint [3] 447949 0
This will be performed every 15 minutes for a total of 6-hours from the point of investigational device application until device removal.
Secondary outcome [4] 447951 0
To assess for the presence of any electrical perturbation of the device signal due to the in vivo environment.
Timepoint [4] 447951 0
This will be assessed for a total of 6-hours from the point of investigational device application until device removal.

Eligibility
Key inclusion criteria
1) At least 18 years of age.
2) Participant is willing to participate in study and comply with protocol requirements.
3) Participants can read and comprehend English.
4) Participants have completed the study Informed Consent Form.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Fear or anxiety of needles, or needle phobia.
2) Has skin lesions, scarring, redness, infection, edema at the application sites or anything that could interfere with device placement or the accuracy of interstitial potassium measurements.
3) Donated blood within 2 weeks prior to the beginning of the study activities, or scheduled to do so throughout study participation (from consent to exit).
4) Pregnant, planning pregnancy or breastfeeding during the study period or producing a positive urine pregnancy test result at the time of enrolment.
5) Any condition that in the Investigator’s opinion would make the participant unable to complete the study or would make it not in the participants best interest to participate in the study.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
ProtonPetal Alpha One devices will be applied to a single arm, and the peripheral IV catheter will be applied to the arm which does not contain any wearable devices. Blood samples will be drawn from the peripheral IV catheter every 15 minutes to measure serum potassium levels, which will be analyzed using two clinically accepted point of care devices, the Abbott iSTAT and the Werfen GEM Premier 5000 blood gas analyzer testing system.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size of 20 participants and 60 device insertions are based on acquisition of appropriate numbers of participants and insertions to adequately evaluate the safety and initial performance of the investigational device.

Descriptive statistics will be reported for participants' baseline characteristics including demographics, medical history, safety parameters, and device deficiencies. All continuous variables will be reported as a mean ± standard deviation if the distribution is normal or a median and interquartile range if the distribution is not normal.

A retrospective approach to fitting the values recorded by the ProtonPetal device to the reference potassium concentration will be performed, using typical gain and offset parameters. Descriptive statistics on the above coefficients will be performed as required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/07/2025
Actual
Date of last participant enrolment
Anticipated
3/09/2025
Actual
Date of last data collection
Anticipated
10/09/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319004 0
Commercial sector/Industry
Name [1] 319004 0
Proton Intelligence Australia Pty Ltd
Country [1] 319004 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Proton Intelligence Australia Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 321469 0
None
Name [1] 321469 0
Address [1] 321469 0
Country [1] 321469 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317616 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 317616 0
Ethics committee country [1] 317616 0
Australia
Date submitted for ethics approval [1] 317616 0
30/05/2025
Approval date [1] 317616 0
01/07/2025
Ethics approval number [1] 317616 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141578 0
A/Prof Ricardo Costa
Address 141578 0
Monash University BASE Facility, 264 Ferntree Gully Rd, Notting Hill, VIC, 3168.
Country 141578 0
Australia
Phone 141578 0
+61 3 9905 6861
Fax 141578 0
Email 141578 0
[email protected]
Contact person for public queries
Name 141579 0
A/Prof Ricardo Costa
Address 141579 0
Monash University BASE Facility, 264 Ferntree Gully Rd, Notting Hill, VIC, 3168.
Country 141579 0
Australia
Phone 141579 0
+61 3 9905 6861
Fax 141579 0
Email 141579 0
[email protected]
Contact person for scientific queries
Name 141580 0
A/Prof Ricardo Costa
Address 141580 0
Monash University BASE Facility, 264 Ferntree Gully Rd, Notting Hill, VIC, 3168.
Country 141580 0
Australia
Phone 141580 0
+61 9905 6861
Fax 141580 0
Email 141580 0
[email protected]

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.