- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07388355
A Usability Study of a Multi-channel ECG Monitoring Device
January 29, 2026 updated by: Wearlinq
WearLinq eWave Patch Study
This study it to evaluate the usability of the WearLinq eWave patch in a general adult population.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrea Brown, MS
- Phone Number: 408-881-2611
- Email: abrown@abioclinical.com
Study Contact Backup
- Name: Chris Daniel
- Email: chris@wearlinq.com
Study Locations
-
-
North Carolina
-
New London, North Carolina, United States, 28127
- ABio Clinical Research Partners
-
Contact:
- Andrea Brown, MS
- Phone Number: 408-881-2611
- Email: wearlinqstudy@abioclinical.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 7 Day Study
Participants will receive and apply the WearLinq patch for 7 consecutive days
|
This device is a wearable multi-channel ECG monitoring device for continuous cardiac rhythm tracking.
|
|
Experimental: Extended Use Cohort
Participants will receive and apply the WearLinq patch for 30 consecutive days
|
This device is a wearable multi-channel ECG monitoring device for continuous cardiac rhythm tracking.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wear Duration
Time Frame: 7 Days
|
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
Time Frame: 7 Days
|
Incidences of self-reported adverse events for the duration of the study
|
7 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Chris Daniel, WearLinq, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
January 22, 2026
First Submitted That Met QC Criteria
January 29, 2026
First Posted (Actual)
February 5, 2026
Study Record Updates
Last Update Posted (Actual)
February 5, 2026
Last Update Submitted That Met QC Criteria
January 29, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLN 0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plans to be provided/Not applicable
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Disease
-
Boston Children's HospitalRecruitingValve Disease, Heart | Valve Heart Disease | Valve Disease, AorticUnited States
-
Centre Chirurgical Marie LannelongueActive, not recruitingValvular Heart Disease | Valve Disease, Heart
-
Yonsei UniversityCompletedMitral Valvular Heart Disease
-
National Defense Medical Center, TaiwanRecruiting
-
Shanghai Zhongshan HospitalCompletedElectrocardiogram, Valvular Heart DiseaseChina, United Kingdom
-
University of PennsylvaniaCompleted
-
Abbott Medical DevicesCompletedAortic Valve Disease | Valvular Heart DiseaseChina
-
Mansoura UniversitySuspendedValve Heart Disease | Elective Cesarean DeliveryEgypt
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingAdult Congenital Heart Disease | Congenital Heart Disease (CHD) | Pediatric Congenital Heart Disease | Heart Transplant PatientsItaly
-
Tulane UniversityRecruitingCardiomyopathies | Valvular Heart Disease | Pericardial DiseaseUnited States
Clinical Trials on eWave Patch
-
Coloplast A/SCompleted
-
Coloplast A/SCompleted
-
En Chu Kong HospitalCompleted
-
GE HealthcareCompleted
-
University of ZurichCompletedAllergic RhinoconjunctivitisSwitzerland
-
Baylor College of MedicineRecruiting
-
Fayoum UniversityNot yet recruitingImpacted Third Molar Tooth
-
nCap MedicalUniversity of PittsburghNot yet recruitingWisdom Teeth | Wisdom Teeth Extraction or Jaw ImplantUnited States
-
Frontier Biotechnologies Inc.CompletedChronic Low Back PainUnited States
-
SuperPatch Limited LLCClarity Science LLCActive, not recruitingStress | AnxietyUnited States