WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).
Public ClinicalTrials.gov record NCT07430605. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07430605
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 82 participants
Conditions and interventions
Conditions
Interventions
- WearME-Pro Patch System Device
- FDA-cleared handheld spirometer (reference comparator) Device
- Cardea SOLO ECG patch (optional subset; exploratory HR reference) Device
Device
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2026
- Primary completion
- Apr 27, 2028
- Completion
- Apr 27, 2028
- Last update posted
- Feb 23, 2026
2026 – 2028
United States locations
- U.S. sites
- 3
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Johns Hopkins | Baltimore | Maryland | 21224 | — |
| LASARRUS Clinic and Research Center Inc. | Baltimore | Maryland | 21230 | — |
| TidalHealth | Salisbury | Maryland | 21801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07430605, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 23, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07430605 live on ClinicalTrials.gov.