U.S., Feb. 25 -- ClinicalTrials.gov registry received information related to the study (NCT07430605) titled 'WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).' on Feb. 10.
Brief 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 ...