A Usability Study of a Multi-channel ECG Monitoring Device

NCT07388355 — Not applicable, Recruiting, 500 participants, Wearlinq

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WearLinq eWave Patch Study

Registry	NCT07388355
Status	Recruiting
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, supportive care
Enrollment	500 (Estimated)
Sponsor	Wearlinq (Industry); collaborators: ABio Clinical Research Partners
Conditions	Healthy Adult Participants, Heart Disease, Arrythmia, Cardiac
Interventions	eWave Patch (Device)
Dates	start 2026-07-06, primary completion 2027-07-31 (estimated), completion 2027-07-31 (estimated), first posted 2026-02-05, last updated 2026-07-21
Locations	1 site in United States

-Summary

This study it to evaluate the usability of the WearLinq eWave patch in a general adult population.

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+Detailed description

Once eligibility is determined, participants will receive and apply the WearLinq patch for 7 consecutive days (or until an endpoint is met). A subset of subjects will be asked to participate in an Extended Use Cohort (30 days).

+Arms and interventions

Arm	Type	Interventions	Description
7 Day Study	Experimental	Device: eWave Patch	Participants will receive and apply the WearLinq patch for 7 consecutive days
Extended Use Cohort	Experimental	Device: eWave Patch	Participants will receive and apply the WearLinq patch for 30 consecutive days

eWave Patch (Device): This device is a wearable multi-channel ECG monitoring device for continuous cardiac rhythm tracking.

+Outcome measures

Primary outcomes

Wear Duration [7 Days]: Days of use until one of the following is reached: patch no longer adheres, signal loss, voluntary removal, or 7 days is achieved
Adverse Events [7 Days]: Incidences of self-reported adverse events for the duration of the study

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Adult >18 years old and able to consent
* Capable of using a smartphone app
* Willing to shave patch area if needed

Exclusion Criteria:

* Planning to undergo an MRI during the study period
* Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies, or any other dermatological conditional that could confound placement or results
* Presence of pacemaker, ICD or other implanted electronic devices
* Open wounds, lesions or infected or inflamed areas of skin at the placement site (left-center of chest/sternum)
* Pregnant or intending to become pregnant during the course of the study

+Locations (1)

Facility	City	Country	Status
ABio Clinical Research Partners	New London, North Carolina	United States	Recruiting

+Investigators

Chris Daniel, Study director, WearLinq, Inc.