Adhesive Wear Time
Conditions
Brief summary
Validating adhesive wear time
Interventions
DEVICEAdhesive
14 day wear
Sponsors
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wear time | 15 days |
Countries
United States
Outcome results
None listed