Gen 2 Battrode Wear Study

Baxter

Status: Enrolling

Conditions: Adhesive Wear Time

Treatments: Device: Adhesive

Study type: Interventional

Funder types: Industry

Identifiers

NCT07256951

BXU610410

Details and patient eligibility

About

Validating adhesive wear time

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

adhesive one

Experimental group

Treatment:

Device: Adhesive

Adhesive two

Experimental group

Treatment:

Device: Adhesive