NCT06565780Completed
Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring Device At Wrist Against Double Auscultation
Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring (OBPM) Device At Wrist Against Double Auscultation: a Multicentric Prospective Clinical Study
Source: ClinicalTrials.gov · Last updated 18 Feb 2025
Brief summary (registry, in English)
This study, with N = 85 participants minimum over 3 visits spread over 23 hours, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G0 for up to 23 hours after initialization in a cohort of subjects representative of the US population. For the study, subjects will be asked to stay seated while measurements are taken at different timepoints.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 19 Aug 2024
- Start date
- Sept 2024
- Primary completion date
- Jan 2025
- Lead sponsor
- Aktiia SA
- Diseases
- High blood pressure
- NCT number
- NCT06565780
What you commit to
- Study type: Interventional
- Participants enrolled: 140
- From Sept 2024 to the primary completion date, Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants with known clotting disorders or currently taking a prescription blood thinner.
Other illness
- Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
- Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.
- Participants suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \> 120bpm) and atrial fibrillation.
- Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, bias the results, by instance a subject presenting a lateral Blood Pressure difference at screening of more than 15 mmHg for the systolic and/or more than 10 mmHg for the diastolic.
Lab values
- Participants suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \< 60mL / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma or arteriovenous fistula.
Other
- Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a day 1 positive urine pregnancy test unless the study participant is known to be not of child-bearing potential.
- A wrist circumference below 14 cm or above 23 cm.
- An upper arm circumference \< 22cm or \> 42cm.
- Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study.
Who the study is looking for
- Participants must be able to provide an informed consent to participate.
- Participant must be willing and able to comply with all of the study procedures and return for a day 2 visit.
- Participants must be 22 to 59 years of age.
- Participant or witness must be able to read or write in English.
Age in the registry: 22 years to 59 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Parameters Research Laboratory Coordinator of this site? Confirm its status | Broomfield | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.