Recruiting

Blood Pressure Measurement

Sponsor:

Jade Healthcare Group Inc.

Code:

NCT03452280

Conditions

Blood Pressure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The JADE wRAP™, a wrist worn cuff to measure blood pressure and its supporting software platform is currently at the final alpha prototype stage of development and is not intended for sale.

There are minimal risks with using the JADE wRAP™ device; however, the likelihood of these risks has been reduced through design limitations on electrical power delivered to the device and of the pressure delivered to the cuff portion. Patients should experience little to no discomfort from the inflation of the JADE wRAP™ cuff.

Conditions

Blood Pressure

Study ID

NCT03452280

Start date

Dec 18, 2017

Status verified date

Feb, 2021

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Must be at least 18 years of age
2. Male or Female
3. Must provide written informed consent prior to the performance of any study-related procedures.

Exclusion Criteria:

1. Subjects who in the opinion of the study staff are too agitated, distressed or who are otherwise unable to cooperate with study procedures
2. Subjects with bigeminy, trigeminy, isolated ventricular premature beat (VPD) or atrial fibrillation or any other condition, in the opinion of the study staff that can result in a significantly irregular heath rhythm.
3. Subjects with signs or recent history of inflammation or infection of the wrists or at the reference clinical test site.

Study Design

Enrollment

140 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Validation Criteria 1 [ Time Frame: April 30, 2018 ]

Central Contacts and Locations

Central contacts

Locations

Alio Health Services Inc.

Recruiting

Ottawa, Ontario, Canada, K2K 2E3

Contacts

More Information

Sponsor

Jade Healthcare Group Inc.

Last update posted

Feb 11, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jade Healthcare Group Inc. on 2021-02-11.