NCT07256951

Brief Summary

Validating adhesive wear time

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
0mo left

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Nov 2025May 2026

Study Start

First participant enrolled

November 12, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Expected
Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

November 21, 2025

Last Update Submit

November 21, 2025

Conditions

Adhesive Wear Time

Outcome Measures

Primary Outcomes (1)

  • Wear time

    15 days

Study Arms (2)

adhesive one

EXPERIMENTAL
Device: Adhesive

Adhesive two

EXPERIMENTAL
Device: Adhesive

Interventions

AdhesiveDEVICE

14 day wear

Adhesive twoadhesive one

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is ≥ 18 years.
  • Completes the consent process as required.
  • Participants can speak and read English fluently.
  • Willing to allow shaving of device application area, as required.
  • Willing to take photos of the application area before wear, daily during wear, and immediately after removal.
  • Willingness to report current known pregnancy.

You may not qualify if:

  • Unable to comply with the study protocol and instructions for wearing the devices for up to 15 days.
  • Any pre-existing breached or compromised skin, skin rash, irritation or infection at the application area.
  • Any incision, wound or scar in the application area.
  • Participants with known skin allergies and sensitivities to adhesives.
  • Participants with scheduled electronic imaging (including magnetic resonance imaging), cardioversion, and/or procedures where device would be removed during the data collection period.
  • Participants with known history of cardiac arrhythmias.
  • Participants with chest anatomies not compatible with secure parasternal placement.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orange County Research Center

Lake Forest, California, 92630, United States

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 1, 2025

Study Start

November 12, 2025

Primary Completion

December 19, 2025

Study Completion (Estimated)

May 15, 2026

Last Updated

December 1, 2025

Record last verified: 2025-11

Locations

US(1)