A Usability Study of a Multi-channel ECG Monitoring Device

NCT07388355 | Not Yet Recruiting FDA Device

• 1 other identifier: CLN 0001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Disease; Arrythmia; Cardiac; Healthy Adult Participants

Keywords

Electrocardiogram; ECG; EKG; Cardiac diagnostic

Outcome Measures

Primary Outcomes (2)

• Wear Duration

  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

  Incidences of self-reported adverse events for the duration of the study

  7 Days

Study Arms (2)

7 Day Study

EXPERIMENTAL

Participants will receive and apply the WearLinq patch for 7 consecutive days

Device: eWave Patch

Extended Use Cohort

EXPERIMENTAL

Participants will receive and apply the WearLinq patch for 30 consecutive days

Device: eWave Patch

Interventions

eWave Patch DEVICE

This device is a wearable multi-channel ECG monitoring device for continuous cardiac rhythm tracking.

7 Day Study; Extended Use Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wearlinq: lead
• ABio Clinical Research Partners: collaborator

Study Sites (1)

ABio Clinical Research Partners

New London, North Carolina, 28127, United States

Location

MeSH Terms

Conditions

Heart Diseases; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris Daniel

  WearLinq, Inc.

  STUDY DIRECTOR

Central Study Contacts

Andrea Brown, MS

CONTACT

408-881-2611; abrown@abioclinical.com

Chris Daniel

CONTACT

chris@wearlinq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)