NCT06698536

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 255 (estimated)
• Sponsor: Aktiia SA · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Aktiia G2C	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).

Timeline

• Start date: 2024-12-20
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-11-21
• Last updated: 2025-05-14

Locations

1 site across 1 country: Switzerland