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NCT07430605 · ClinicalTrials.gov registry record · NA
WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).
A NA study, sponsored by LASARRUS Clinic and Research Center.
- Not yet
- Registry status
- NA
- Development phase
- 82
- Enrollment target
NCT07430605 is a NA study that has not yet begun recruiting, run by LASARRUS Clinic and Research Center. The registered enrollment target is 82 participants.
The verdict
NCT07430605, a NA study, has not yet begun recruiting, sponsored by LASARRUS Clinic and Research Center.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 82 participants
- Enrollment target
Study 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.
Interventions
- DEVICE WearME-Pro Patch System
- DEVICE FDA-cleared handheld spirometer (reference comparator)
- DEVICE Cardea SOLO ECG patch (optional subset; exploratory HR reference)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2026-05-01 |
| Est. Completion | 2028-04-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07430605
The ClinicalTrials.gov registry entry for NCT07430605 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LASARRUS Clinic and Research Center, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which WearME-Pro Patch System is the first listed.
NCT07430605 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07430605 about?
NCT07430605 is a clinical study titled "WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).". 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-P...
What is the current status of trial NCT07430605?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 82 participants. The study started on 2026-05-01. Estimated completion is 2028-04-28.
What interventions are being tested in trial NCT07430605?
The interventions under investigation include: WearME-Pro Patch System (DEVICE), FDA-cleared handheld spirometer (reference comparator) (DEVICE), Cardea SOLO ECG patch (optional subset; exploratory HR reference) (DEVICE).
Who is sponsoring clinical trial NCT07430605?
This trial is sponsored by LASARRUS Clinic and Research Center, which has 2 total clinical trials registered on ClinicalTrials.gov.
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