RecruitingNot ApplicableNCT07256951

Gen 2 Battrode Wear Study


Sponsor

Baxter Healthcare Corporation

Enrollment

30 participants

Start Date

Nov 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Validating adhesive wear time


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Participant is ≥ 18 years.
  • Completes the consent process as required.
  • Participants can speak and read English fluently.
  • Willing to allow shaving of device application area, as required.
  • Willing to take photos of the application area before wear, daily during wear, and immediately after removal.
  • Willingness to report current known pregnancy.

Exclusion Criteria8

  • Unable to comply with the study protocol and instructions for wearing the devices for up to 15 days.
  • Any pre-existing breached or compromised skin, skin rash, irritation or infection at the application area.
  • Any incision, wound or scar in the application area.
  • Participants with known skin allergies and sensitivities to adhesives.
  • Participants with scheduled electronic imaging (including magnetic resonance imaging), cardioversion, and/or procedures where device would be removed during the data collection period.
  • Participants with known history of cardiac arrhythmias.
  • Participants with chest anatomies not compatible with secure parasternal placement.
  • 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.

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Interventions

DEVICEAdhesive

14 day wear


Locations(1)

Orange County Research Center

Lake Forest, California, United States

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NCT07256951