Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT07256951
Eligibility Criteria:
Inclusion Criteria:
1. Participant is ≥ 18 years.
2. Completes the consent process as required.
3. Participants can speak and read English fluently.
4. Willing to allow shaving of device application area, as required.
5. Willing to take photos of the application area before wear, daily during wear, and immediately after removal.
6. Willingness to report current known pregnancy.
Exclusion Criteria:
1. Unable to comply with the study protocol and instructions for wearing the devices for up to 15 days.
2. Any pre-existing breached or compromised skin, skin rash, irritation or infection at the application area.
3. Any incision, wound or scar in the application area.
4. Participants with known skin allergies and sensitivities to adhesives.
5. Participants with scheduled electronic imaging (including magnetic resonance imaging), cardioversion, and/or procedures where device would be removed during the data collection period.
6. Participants with known history of cardiac arrhythmias.
7. Participants with chest anatomies not compatible with secure parasternal placement.
8. Use of clothing or garment that can dislodge or loosen the patch or bras with underwires or other worn items that might interfere with the devices under study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07256951
Study Brief:
Protocol Section:
NCT07256951