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Trial registered on ANZCTR


Registration number
ACTRN12618001028291p
Ethics application status
Not yet submitted
Date submitted
13/06/2018
Date registered
19/06/2018
Date last updated
30/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of safety, accuracy and ease of use of the Tournicare blood pressure (BP) monitor compared with a clinically validated BP monitor based on multiple measurements on up to 30 participants.
Scientific title
Pilot study to assess safety, accuracy and ease of use of the Tournicare BP monitor compared with a clinically validated BP monitor based on multiple measurements on up to 30 generally healthy adult participants.
Secondary ID [1] 295186 0
Sponsor: Tournicare Pty Ltd
Sponsor issued trial number: Tcarev1.2
Universal Trial Number (UTN)
U1111-1215-5856
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Pressure 308322 0
Condition category
Condition code
Cardiovascular 307320 307320 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Assessment of safety, accuracy and ease of use of the Tournicare BP monitor.
Location: Outerspace Design Office, Richmond, Melbourne, Australia.
Materials used: Tournicare BP monitor prototype, clinically validated upper arm BP monitor.
Each participant will spend approximately 15 minutes with a registered nurse (RN). Firstly the RN takes consent. Blood pressure will be measured in a quiet room with no stimulus (such as talking to participant, measuring arm or even patient reading/looking at phone), with the patient in the seated position, back and arm supported, Tournicare and/or cuff at heart level, after 5 minutes of rest. This is to ensure reproducibility. The participants will self-measure blood pressure with both Tournicare and a validated BP monitor. The RN will then perform 3 pairs of simultaneous BP measurements with e.g. Tournicare applied to the right upper arm and a validated BP monitor on the left. It is not uncommon for BP to differ slightly from left to right arm, this is why Tournicare and the validated BP monitor are then swapped and followed by another 3 pairs of measurements. During or after the process the participants will be asked questions regarding usability and user experience. In addition to BP measurements, age, gender and upper arm width and/or circumference will be recorded.
Intervention code [1] 301525 0
Prevention
Intervention code [2] 301526 0
Treatment: Devices
Comparator / control treatment
Comparator. The Tournicare BP monitor will be compared with a common upper arm home BP monitor, like an Omron HEM 7121, that is clinically validated according to the protocol of the European Society of Hypertension.
Control group
Active

Outcomes
Primary outcome [1] 306281 0
Assess safety of the Tournicare BP monitor in generally healthy participants. All participants will be assessed by the RN after the measurements described in the intervention section, any adverse events, including known possible events like pain and bruising, will be recorded on the case report form.
Timepoint [1] 306281 0
Immediately after completion of the intervention.
Primary outcome [2] 306282 0
Assess accuracy of the Tournicare BP monitor compared with a clinically validated BP monitor. The blood pressure measurements described in the intervention section will be recorded on the case report form by the RN for each individual participant. After all participants measurements have been recorded, they will be analysed by the Principal Investigator, Dr Geoffrey Toogood, interventional Cardiologist.
Timepoint [2] 306282 0
7 days after completion of the interventions.
Secondary outcome [1] 348054 0
Assess ease of use of the Tournicare BP monitor. A Market researcher will interview participants about the user experience. The market researcher will take notes of the responses and will summarise these in a written report.
Timepoint [1] 348054 0
Interview: immediate after completion of the blood pressure measurements described in the intervention section.
Report: 7 days after completion of the interventions.

Eligibility
Key inclusion criteria
Generally healthy adult participants
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People with large, obese arms (the Tournicare prototype adjusts to different arm widths but has an upper limit of 11cm), high blood pressure, a change from the normal heartbeat, thickening/hardening of the artery walls, low oxygen levels, diabetes, pregnancy, removal of one or both breasts, kidney disease or severe blood flow problems or blood disorders.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a pre market, prospective, non-randomised, single site, first in human safety and feasibility study. The number of participants is based on the European Society of Hypertension protocol for validating BP monitors. BP measurements with the Tournicare BP monitor will be directly compared with BP measurements taken with a clinically validated BP monitor.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/08/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299772 0
Commercial sector/Industry
Name [1] 299772 0
Tournicare Pty Ltd
Country [1] 299772 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Tournicare Pty Ltd
Address
710 Docklands Street, Docklands, Victoria, 3008
Country
Australia
Secondary sponsor category [1] 299119 0
None
Name [1] 299119 0
Address [1] 299119 0
Country [1] 299119 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300663 0
Bellberry Limited
Ethics committee address [1] 300663 0
Ethics committee country [1] 300663 0
Australia
Date submitted for ethics approval [1] 300663 0
20/06/2018
Approval date [1] 300663 0
Ethics approval number [1] 300663 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2773 2773 0 0
/AnzctrAttachments/375332-Case Report Form Tcarev1.2.pdf (Other)

Contacts
Principal investigator
Name 84386 0
Dr Geoffrey Toogood
Address 84386 0
Peninsula Health - Frankston Hospital
2 Hastings Road, Frankston, Victoria, 3199
Country 84386 0
Australia
Phone 84386 0
+61418396791
Fax 84386 0
Email 84386 0
gdtoogood@ozemail.com.au
Contact person for public queries
Name 84387 0
Niels van Sparrentak
Address 84387 0
Tournicare Pty Ltd
710 Collins Street, Docklands, Victoria, 3008
Country 84387 0
Australia
Phone 84387 0
+61 1300 763 130
Fax 84387 0
Email 84387 0
nvanspar@tournicare.com.au
Contact person for scientific queries
Name 84388 0
Niels van Sparrentak
Address 84388 0
Tournicare Pty Ltd
710 Collins Street, Docklands, Victoria, 3008
Country 84388 0
Australia
Phone 84388 0
+ 61 1300 763 130
Fax 84388 0
Email 84388 0
nvanspar@tournicare.com.au

No information has been provided regarding IPD availability


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.