OBPM_COYOTE2024 Physiological Data Recording with the Calibration-free Optical Aktiia G2C Device At Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff

Aktiia

Status: Enrolling

Conditions: Hypertension

Treatments: Device: Aktiia G2C

Study type: Interventional

Funder types: Industry

Identifiers

NCT06698536

OBPM_COYOTE2024

Details and patient eligibility

About

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.

Enrollment: 255 estimated patients

Sex: All

Ages: 21 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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255 participants in 1 patient group

Aktiia G2C cohort

Other group

Description:

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).

Treatment:

Device: Aktiia G2C