NCT06368206Recruiting
Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM)
Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM) Algorithm That Requires No Calibration with an External Cuff: a Single-center Prospective Clinical Study
Source: ClinicalTrials.gov · Last updated 17 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The present study, OBPM\_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 85 (estimated)
- First submitted
- 4 Apr 2024
- Start date
- 25 Jun 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Aktiia SA
- Diseases
- High blood pressure
- NCT number
- NCT06368206
What you commit to
- Study type: Interventional
- Planned participants: 85
- From 25 Jun 2024 to the primary completion date, 31 Dec 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.
Other illness
- Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \> 120bpm) and atrial fibrillation
Lab values
- Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \< 30mL/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula
Other
- Amputated index fingers
- Damaged/injured skin at index fingers
- Damaged/injured skin at wrists
- Pregnant women
- Polyneuropathy
Who the study is looking for
- Subjects aged 21 to 85yo
- Subjects fluent in written and spoken French
- Subjects agreeing to attend the study visit and follow study procedures
- Subjects that have signed the informed consent form.
Age in the registry: 21 years to 85 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 |
|---|---|---|---|
| CHUV Coordinator of this site? Confirm its status | Lausanne | Switzerland | Recruiting |
Related publications
- Comparison of two validated oscillometric devices in a home-like setup reveals pronounced blood pressure differences and reduced precision.Hypertens Res · 2026 · PMID 41514019
This page is information, not medical advice. Discuss any trial with your doctor.