A Usability Study of a Multi-channel ECG Monitoring Device
Purpose
This study it to evaluate the usability of the WearLinq eWave patch in a general adult population.
Conditions
- Healthy Adult Participants
- Heart Disease
- Arrythmia
- Cardiac
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 7 Day Study |
Participants will receive and apply the WearLinq patch for 7 consecutive days |
|
|
Experimental Extended Use Cohort |
Participants will receive and apply the WearLinq patch for 30 consecutive days |
|
Recruiting Locations
ABio Clinical Research Partners
New London, North Carolina 28127
New London, North Carolina 28127
More Details
- Status
- Recruiting
- Sponsor
- Wearlinq
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).