Gen 2 Battrode adhesive wear test
Gen 2 Battrode Wear Study
This test checks how long the Gen 2 Battrode adhesive stays on adult skin when worn for up to 15 days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baxter Healthcare Corporation Industry-sponsored |
| Locations | 1 site (Lake Forest, California) |
| Trial ID | NCT07256951 on ClinicalTrials.gov |
What this trial studies
Adults 18 and older will have the Gen 2 Battrode adhesive applied to a shaved skin site and will be asked to wear it for up to 15 days while taking photos of the site before, during, and after wear. The protocol excludes people with compromised or irritated skin, known adhesive allergies, scheduled procedures requiring device removal, or a history of cardiac arrhythmias. Data collection relies on participant photos and site visits at a single research center in Lake Forest, California, sponsored by Baxter Healthcare Corporation. Participants must be able to read and speak English and follow study instructions throughout the wear period.
Who should consider this trial
Good fit: Adults aged 18 or older with intact, non-irritated skin at the application site who can follow instructions, attend the Lake Forest site, and take daily photos are ideal candidates.
Not a fit: People with breached or sensitive skin, known adhesive allergies, scheduled procedures requiring device removal, a history of cardiac arrhythmias, or inability to comply with daily photo/reporting requirements are unlikely to benefit.
Why it matters
Potential benefit: If successful, the adhesive could allow longer, more reliable wear of medical devices, reducing the need for reapplication and interruptions in monitoring.
How similar studies have performed: Other wearable-adhesive wear-time studies have shown modest success with improved adhesives, but this specific Gen 2 Battrode adhesive appears to be a novel product under clinical testing.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lake Forest, California
- Orange County Research Center — Lake Forest, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.