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

A

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)

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

Trial contacts and locations

1

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Central trial contact

Pascale Vermare

Data sourced from clinicaltrials.gov

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