A Usability Study of a Multi-channel ECG Monitoring Device

Wearlinq

Status: Not yet enrolling

Conditions: Healthy Adult Participants; Arrythmia; Cardiac; Heart Disease

Treatments: Device: eWave Patch

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07388355

CLN 0001

Details and patient eligibility

About

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

Full 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).

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

7 Day Study

Experimental group

Description:

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

Treatment:

Device: eWave Patch

Extended Use Cohort

Experimental group

Description:

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

Treatment:

Device: eWave Patch