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NOT YET RECRUITING
NCT07430605
NA

WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).

Sponsor: LASARRUS Clinic and Research Center

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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).

DEVICE

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