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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: Clinical Trial NA study, sponsored by LASARRUS Clinic and Research Center.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Agreement will be assessed using paired daily measurements of FEV1 collected during home use. The outcome will be summarized as the mean difference (WearME-Pro - handheld spirometer) in FEV1 (liters) across paired measurements.
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 |
What is known before NCT07430605 opens enrollment
NCT07430605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which WearME-Pro Patch System is the first listed.
NCT07430605 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07430605's enrollment target sits among peer trials
82 990th of 2000 higher than 1,009 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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