Trials / Terminated
TerminatedNCT06002971
CONNEQT Pulse Validation Study
Validation of the CONNEQT Blood Pressure Monitoring System in a Pregnant Patient Population
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 41 (actual)
- Sponsor
- Mount Carmel Health System · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to validate the accuracy of the CONNEQT Pulse blood pressure monitoring system for the measurement of blood pressure as compared to a gold standard, auscultatory sphygmomanometer in a pregnant population.
Detailed description
Clinical staff will review patient's medical record to determine eligibility. Following informed consent, a brief medical history will be collected. Serial blood pressure measurements will be collected to compare an auscultatory sphygmomanometer to blood pressure measurements of the CONNEQT Pulse blood pressure monitoring system in a pregnant population according to ISO protocol 81060-2.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Blood pressure measurement | Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2. |
Timeline
- Start date
- 2023-08-21
- Primary completion
- 2025-06-03
- Completion
- 2025-06-03
- First posted
- 2023-08-21
- Last updated
- 2026-03-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06002971. Inclusion in this directory is not an endorsement.