ClinicalTrials.gg
CompletedNCT07256951Updated Sep 23, 2026

Gen 2 Battrode Wear Study

An interventional study of Adhesive in Adhesive Wear Time, sponsored by Baxter Healthcare Corporation. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Baxter Healthcare Corporation · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Validating adhesive wear time

02

Conditions studied

  • Adhesive Wear Time
03

In context

Lead sponsor

Baxter Healthcare Corporation is the lead sponsor of 80 studies on the registry; 1 is open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    adhesive one

    Device: Adhesive

  • Experimental
    Adhesive two

    Device: Adhesive

Interventions

  • DeviceAdhesive

    14 day wear

06

What researchers measure

Primary outcomes

  1. Wear time

    Time frame: 15 days

07

Study locations

1 site
  • Orange County Research Center
    Lake Forest, California 92630, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07256951
Responsible party
Sponsor
First posted
Dec 1, 2025
Start date
Nov 12, 2025
Primary completion
Dec 23, 2025
Completion
May 15, 2026
Last update
Sep 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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