MedTrace Logo

Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation

NCT04027777 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2026-04-06

No results posted yet for this study

Summary

Single-centre prospective observational study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against blood pressure measurements obtained by double auscultation at the upper arm during four weeks

Conditions

  • Blood Pressure

Interventions

DEVICE

Aktiia.product-P0

The optical signals at the wrist are recorded non-invasively by means of the Aktiia.product-P0 investigational device. The BP measurements are further determined from these optical signals and are compared to the reference double auscultation BP readings. A reference-control volume clamp BP reading is recorded simultaneously.

Sponsors & Collaborators

  • University of Lausanne Hospitals

    collaborator OTHER

  • Aktiia SA

    lead INDUSTRY

Principal Investigators

  • Gregoire Wuerzner, MD · CHUV

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-06
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04027777 on ClinicalTrials.gov