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WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).
Sponsor: LASARRUS Clinic and Research Center
Summary
This Phase II investigation evaluates the safety, usability, and clinical performance of the WearME-Pro patch system for remote monitoring of adults with COPD in a home-use environment. The protocol includes two components: (A) a \~1-month summative usability/human factors evaluation of the WearME-Pro patch, mobile app, and clinician dashboard; and (B) a 10-month longitudinal home-use study comparing WearME-Pro predicted lung function metrics (FEV1, FVC, FEV1/FVC) to an FDA-cleared handheld spirometer, with an adherence target of ≥85%. WearME-Pro outputs are investigational and are not used to direct clinical decisions during the study.
Official title: WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor)
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
82
Start Date
2026-05-01
Completion Date
2028-04-28
Last Updated
2026-02-24
Healthy Volunteers
No
Interventions
WearME-Pro Patch System
Wearable non-invasive monitoring platform with two sensor modules, mobile app, and optional clinician dashboard; patch retainer supports continuous wear up to \~28 days per retainer; scheduled daily recording windows typically \~30-180 min/day.
FDA-cleared handheld spirometer (reference comparator)
Daily handheld spirometry collected at home to provide reference standards for paired comparisons with WearME-Pro predicted lung function (FEV1, FVC, FEV1/FVC).
Cardea SOLO ECG patch (optional subset; exploratory HR reference)
Optional FDA-cleared single-use ECG patch worn up to 24-48 hours at Baseline and End of Study for exploratory heart-rate reference comparisons.
Locations (3)
Johns Hopkins
Baltimore, Maryland, United States
LASARRUS Clinic and Research Center Inc.
Baltimore, Maryland, United States
TidalHealth
Salisbury, Maryland, United States