None listed
Conditions
Brief summary
This study aims to assess the ProtonPetal Alpha One’s ability to track potassium levels at rest, when compared to current on market PoC reference measurement devices. Findings from this trial will guide future clinical evaluations and device refinement.
Interventions
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 nu
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.
Sponsors
Proton Intelligence Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
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.
Outcome results
None listed