NCT07430605

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: LASARRUS Clinic and Research Center · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

WearME-Pro is a wearable, non-invasive physiological monitoring platform with two identical sensor modules, a patient-facing mobile application, and an optional clinician dashboard. For longitudinal use, the sensor modules are inserted into an adhesive patch retainer intended for prolonged skin contact (target up to \~28 days continuous wear per retainer; patch replacement per IFU/study procedures). The patch remains on the skin continuously between scheduled sessions; the mobile app initiates daily recording windows (typically totaling \~30-180 minutes/day), and sensors remain in low-power mode outside those windows. In the longitudinal component, participants complete daily WearME-Pro sessions plus daily handheld spirometry to enable paired comparisons. A subset of participants may optionally wear an FDA-cleared ECG patch (Cardea SOLO) for 24-48 hours at Baseline and End of Study as an exploratory heart-rate reference. Participants also complete daily symptom reporting and periodic questionnaires, with check-ins per the protocol schedule.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-04-28
• Completion: 2028-04-28
• First posted: 2026-02-24
• Last updated: 2026-02-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study