A Usability Study of a Multi-channel ECG Monitoring Device

January 29, 2026 updated by: Wearlinq

WearLinq eWave Patch Study

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

Study Overview

Status

Not yet recruiting

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 7 Day Study
Participants will receive and apply the WearLinq patch for 7 consecutive days
This device is a wearable multi-channel ECG monitoring device for continuous cardiac rhythm tracking.
Experimental: Extended Use Cohort
Participants will receive and apply the WearLinq patch for 30 consecutive days
This device is a wearable multi-channel ECG monitoring device for continuous cardiac rhythm tracking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wear Duration
Time Frame: 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
7 Days
Adverse Events
Time Frame: 7 Days
Incidences of self-reported adverse events for the duration of the study
7 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Chris Daniel, WearLinq, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plans to be provided/Not applicable

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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