Recruiting

Observational Study

Sponsor:

Baxter Healthcare Corporation

Code:

NCT07256951

Conditions

Adhesive Wear Time

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Adhesive

Study Details

Brief summary:

Validating adhesive wear time

Conditions

Adhesive Wear Time

Study ID

NCT07256951

Start date

Nov 12, 2025

Status verified date

Nov, 2025

Completion date

May 15, 2026

Anticipated

Primary completion date

Dec 19, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: adhesive one

experimental: Adhesive two

Interventions

Adhesive

14 day wear

Primary outcome measure

  • Wear time [ Time Frame: 15 days ]

Central Contacts and Locations

Locations

Orange County Research Center

Recruiting

Lake Forest, California, United States, 92630

Contacts

Orange County Research Center

7145509990

More Information

Sponsor

Baxter Healthcare Corporation

Last update posted

Dec 1, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baxter Healthcare Corporation on 2025-12-01.