Gen 2 Battrode Wear Study

NCT ID: NCT07256951

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-12

Study Completion Date

2026-05-15

Brief Summary

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Validating adhesive wear time

Detailed Description

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Conditions

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Adhesive Wear Time

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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adhesive one

Group Type EXPERIMENTAL

Adhesive

Intervention Type DEVICE

14 day wear

Adhesive two

Group Type EXPERIMENTAL

Adhesive

Intervention Type DEVICE

14 day wear

Interventions

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Adhesive

14 day wear

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Orange County Research Center

Lake Forest, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Orange County Research Center

Role: primary

7145509990

Other Identifiers

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BXU610410

Identifier Type: -

Identifier Source: org_study_id

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