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

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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).
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Aktiia G2C cohort

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).

Group Type OTHER

Aktiia G2C

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aktiia SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHUV Service de Néphrologie et d'Hypertension

Lausanne, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Pascale Vermare

Role: CONTACT

+41 32 552 20 52

Facility Contacts

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Grégoire WUERZNER, Prof. Med.

Role: primary

+41 21 314 02 23

Other Identifiers

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OBPM_COYOTE2024

Identifier Type: -

Identifier Source: org_study_id

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