Study Results
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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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-11-12
2026-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
NONE
Study Groups
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adhesive one
Adhesive
14 day wear
Adhesive two
Adhesive
14 day wear
Interventions
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Adhesive
14 day wear
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Responsible Party
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Locations
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Orange County Research Center
Lake Forest, California, United States
Countries
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Facility Contacts
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Orange County Research Center
Role: primary
Other Identifiers
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BXU610410
Identifier Type: -
Identifier Source: org_study_id
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