Recruiting NCT07388355
A Usability Study of a Multi-channel ECG Monitoring Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: eWave Patch.
- Who it may be relevant to
- Registry conditions: Healthy Adult Participants, Heart Disease, Arrythmia, Cardiac. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
WearLinq eWave Patch Study
Overview
This study it to evaluate the usability of the WearLinq eWave patch in a general adult population.
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).
Interventions
- Device eWave Patch
This device is a wearable multi-channel ECG monitoring device for continuous cardiac rhythm tracking.
Primary outcome measures
- Wear Duration [Time frame: 7 Days]
- Adverse Events [Time frame: 7 Days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- ABio Clinical Research Partners — New London
Identifiers
NCT: NCT07388355 · CLN 0001