NCT07256951NARecruitingAccepts Healthy Volunteers
Gen 2 Battrode Wear Study
Baxter Healthcare Corporation
Start Date
11/12/2025
Completion Date
5/15/2026
Summary
Validating adhesive wear time
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DEVICE
Adhesive
Conditions
Adhesive Wear Time
Locations
Orange County Research Center
Lake Forest, California 92630
United States