OBPM_COYOTE2024 Physiological Data Recording With the Calibration-free Optical Aktiia G2C Device at Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff
OBPM_COYOTE2024 Physiological Data Recording With the Calibration-free Optical Aktiia G2C Device at Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff: a Single-center, Prospective Clinical Study
Aktiia SA
255 participants
Dec 20, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria13
- 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
Interventions
Study subjects are asked to stay seated while 3 successive measurements are taken with the Aktiia G2C device under investigation (BP and PR) and two references (Aktiia Bracelet G2 and Aktiia Init I1 oscillometric cuff).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06698536