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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06698536

Acronym

COYOTE2024

Enrollment

255

Registered

2024-11-21

Start date

2024-12-20

Completion date

2026-12-31

Last updated

2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, blood pressure

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.

Interventions

DEVICEAktiia 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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

Study subjects are asked to stay seated while 3 successive measurements are taken with the device under investigation (BP and PR) and two references (Aktiia Bracelet G2 and Aktiia Init I1 oscillometric cuff).

Eligibility

Sex/Gender

ALL

Age

21 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Data set build	Baseline	Number of subjects including three assessments of blood pressure using Aktiia G2C Clinical, alongside three assessments of blood pressure with Aktiia Bracelet G2 and three values of blood pressure generated with the Aktiia Init I1 oscillometric cuff

Countries

Switzerland

Contacts

Primary ContactPascale Vermare

pascale.vermare@aktiia.com+41 32 552 20 52

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026