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Trial registered on ANZCTR


Registration number
ACTRN12625000182493
Ethics application status
Approved
Date submitted
12/12/2024
Date registered
17/02/2025
Date last updated
17/02/2025
Date data sharing statement initially provided
17/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the Safety and Performance of ProtonPetal Alpha One for Monitoring Potassium Levels in Healthy People
Scientific title
Feasibility assessment of ProtonPetal Alpha One’s safety and performance in the continuous monitoring of interstitial potassium measurements in healthy adults.
Secondary ID [1] 313400 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Potassium dysregulation (Hypokalemia) 335772 0
Chronic Kidney Disease (CKD) 335773 0
Potassium dysregulation (Hyperkalemia) 336622 0
Condition category
Condition code
Renal and Urogenital 332334 332334 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 GP clinic. Participants will be assessed for study inclusion that will include a blood test and electrocardiogram. They will then undergo and 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 and glucose levels which will be analyzed in a certified pathology laboratory. During the study, participants will also ingest a known potassium concentration in the form of a single Chlorvescent tablet at the 3 hour mark following wearable device and catheter application, This Chlorvescent tablet contains; 14 mmol K+, 8 mmol Cl-, 1.1 mmol CO32-, and 3.8 mmol HCO-3. The tablet will be prepared by the nurse by dissolving a single tablet in 250 mL of water.

During the study, the clinical nurse will perform the preparation and administration of the Chlorvescent tablet to ensure compliance with the intervention protocol.
Intervention code [1] 330010 0
Treatment: Devices
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340133 0
To characterise the safety of the ProtonPetal Alpha One device as characterized by adverse device effects.
Timepoint [1] 340133 0
Safety data will be collected at all participant visits, starting from the point of participant enrolment (study visit 1), the safety screening (study visit 2) and the day of intervention (study visit 3). Safety data will also be collected up to the post-intervention phone call follow up 7 days after study visit 3. During the 7 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.
Primary outcome [2] 340667 0
To characterise and generate early feasibility data for the ProtonPetal Alpha One device.
Timepoint [2] 340667 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] 442034 0
To characterise the ProtonPetal Alpha One's ability to detect fluctuations to interstitial potassium concentrations following potassium supplement ingestion.
Timepoint [1] 442034 0
This will be performed 3 hours into the specified 6 hour device wear time. Data will be collected every 15 minutes between the time point of 3 hours and 6 hours from the point of device application.
Secondary outcome [2] 442035 0
To characterise the warmup time of the ProtonPetal Alpha One device.
Timepoint [2] 442035 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 [3] 442036 0
To monitor additional serum analytes (Chloride) for assessment of device interference.
Timepoint [3] 442036 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] 442037 0
To assess for the presence of any electrical perturbation of the device signal due to the clinical environment setting.
Timepoint [4] 442037 0
This will be assessed for a total of 6-hours from the point of investigational device application until device removal.
Secondary outcome [5] 442038 0
To assess the duration over which the ProtonPetal Alpha One device remains operational post insertion.
Timepoint [5] 442038 0
This will be assessed for a total of 6-hours from the point of investigational device application until device removal.
Secondary outcome [6] 442890 0
To assess the function of the ProtonPetal Alpha One device in monitoring interstitial potassium concentrations.
Timepoint [6] 442890 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 [7] 444745 0
To characterise the signal drift of the ProtonPetal Alpha One device.
Timepoint [7] 444745 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 [8] 444746 0
To characterise the sensitivity of the ProtonPetal Alpha One device.
Timepoint [8] 444746 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 [9] 444747 0
To monitor additional serum analytes (Bicarbonate) for assessment of device interference.
Timepoint [9] 444747 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 [10] 444748 0
To monitor additional serum analytes (Creatinine) for assessment of device interference.
Timepoint [10] 444748 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 [11] 444749 0
To monitor additional serum analytes (Urea) for assessment of device interference.
Timepoint [11] 444749 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 [12] 444750 0
To monitor additional serum analytes (Sodium) for assessment of device interference.
Timepoint [12] 444750 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 [13] 444751 0
To monitor additional serum analytes (Glucose) for assessment of device interference.
Timepoint [13] 444751 0
This will be performed every 15 minutes 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) Known allergy to polyurethane, polyvinyl chloride, acesulfame potassium, aspartame, citric acid, leucine, macrogol 6000, sorbitol, blackcurrant flavour 502009 AP0551.
2) Baseline haematology panel readings outside of the pathology laboratories published reference range, and deemed by the investigator as clinically significant,
3) Baseline UEC panel readings outside of the pathology laboratories published reference range, and deemed by the investigator as clinically significant,
4) Abnormal ECG readings detecting heart arrhythmia, elevated heart rate or other phenotypes deemed a potential risk by a qualified medical practitioner.
5) Underlying heart/kidney impairment.
6) 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.
7) Pregnant, planning pregnancy or breastfeeding during the study period or producing a positive urine pregnancy test result at the time of enrolment.
8) 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
Single group
Other design features
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
24/03/2025
Actual
Date of last participant enrolment
Anticipated
23/06/2025
Actual
Date of last data collection
Anticipated
23/06/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317840 0
Commercial sector/Industry
Name [1] 317840 0
Proton Intelligence Australia Pty Ltd
Country [1] 317840 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Proton Intelligence Australia Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320210 0
None
Name [1] 320210 0
Address [1] 320210 0
Country [1] 320210 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316523 0
Bellberry Human Research Ethics Committee H
Ethics committee address [1] 316523 0
https://bellberry.com.au/
Ethics committee country [1] 316523 0
Australia
Date submitted for ethics approval [1] 316523 0
24/09/2024
Approval date [1] 316523 0
08/10/2024
Ethics approval number [1] 316523 0

Summary
Brief summary
This study aims to evaluate the safety and functionality of the ProtonPetal Alpha One device, focusing on generating early feasibility data regarding its performance. The device will measure participants' interstitial potassium levels, and these measurements will be retrospectively compared to standard clinical blood potassium measurements, both during baseline conditions and after introducing a potassium challenge.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138150 0
Dr Shashi Wijesinghe
Address 138150 0
Durrant Medical Clinic, 29 Durrant street, Brighton, VIC, 3186
Country 138150 0
Australia
Phone 138150 0
+61 395925133
Fax 138150 0
Email 138150 0
[email protected]
Contact person for public queries
Name 138151 0
Shashi Wijesinghe
Address 138151 0
Durrant Medical Clinic, 29 Durrant street, Brighton, VIC, 3186
Country 138151 0
Australia
Phone 138151 0
+61 395925133
Fax 138151 0
Email 138151 0
[email protected]
Contact person for scientific queries
Name 138152 0
Shashi Wijesinghe
Address 138152 0
Durrant Medical Clinic, 29 Durrant street, Brighton, VIC, 3186
Country 138152 0
Australia
Phone 138152 0
+61 395925133
Fax 138152 0
Email 138152 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24399Clinical study report  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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