Trials / Completed
CompletedNCT05599308
Evaluation of Blood Pressure Monitor With AFib Screening Feature
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 574 (actual)
- Sponsor
- Omron Healthcare Co., Ltd. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
Summary
This study aims to evaluate the safety and effectiveness of the Omron blood pressure (BP) monitor with AFib screening feature. The primary outcome is to validate if the Omron BP-monitor with AFib screening feature meets acceptance criteria in sensitivity and specificity. The acceptance criteria of the sensitivity and specificity should be statistically non-inferior to those of primary predicate device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OMRON blood pressure monitor with AFib screening feature | Blood pressure measurement by an oscillometric blood pressure monitor |
| DEVICE | Microlife WatchBP Home A | Blood pressure measurement by an oscillometric blood pressure monitor |
Timeline
- Start date
- 2022-09-06
- Primary completion
- 2023-04-11
- Completion
- 2023-04-11
- First posted
- 2022-10-31
- Last updated
- 2023-04-28
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05599308. Inclusion in this directory is not an endorsement.