A Usability Study of a Multi-channel ECG Monitoring Device
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWearlinq
About this trial
This study it to evaluate the usability of the WearLinq eWave patch in a general adult population.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult >18 years old and able to consent
Capable of using a smartphone app
Willing to shave patch area if needed
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
eWave Patch
DeviceThis device is a wearable multi-channel ECG monitoring device for continuous cardiac rhythm tracking.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: 7 Day StudyExperimental treatment 1 intervention
Group B: Extended Use CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
7 Days2
Adverse Events
Incidences of self-reported adverse events for the duration of the study
Time frame
7 DaysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wearlinq
Lead sponsor
ABio Clinical Research Partners
Collaborator
Source ClinicalTrials.gov