NCT06698536 OBPM_COYOTE2024 Physiological Data Recording With the Calibration-free Optical Aktiia G2C Device at Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff
| NCT ID | NCT06698536 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aktiia SA |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 255 participants |
| Start Date | 2024-12-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 255 participants in total. It began in 2024-12-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The present study, OBPM\_COYOTE2024, with N = 255 participants minimum over 1 visit (lasting \~15min), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational device together with Aktiia G2 Bracelet and Aktiia Init I1 oscillometric cuff within a cohort of subjects characterized by a wide variety of phenotypes. The resulting dataset will support research and development activities conducted by AKTIIA SA out of the study context.
Eligibility Criteria
Inclusion Criteria: * Subjects aged 21 to 85yo * Subjects or witnesses 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. Exclusion Criteria: * Amputated index fingers * Damaged/injured skin at index fingers * Damaged/injured skin at wrists * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * Subjects with diabetes * Subjects with marked renal dysfunctions (eGFR \< 30mL/min/1.73 m2) * Subjects with untreated hyper-/hypothyroidism * Subjects with pheochromocytoma * Subjects with Raynaud's disease * Subjects with an arteriovenous fistula * Women in known pregnancy * History of polyneuropathy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06698536 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 85 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06698536 currently recruiting?
Yes, NCT06698536 is actively recruiting participants. Contact the research team at pascale.vermare@aktiia.com for enrollment information.
Where is the NCT06698536 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT06698536 clinical trial?
NCT06698536 is sponsored by Aktiia SA. The trial plans to enroll 255 participants.