Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-05 @ 8:11 AM
Study NCT ID:
NCT07430605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-component protocol. Part A is a parallel-assignment summative usability study in people with COPD: Training (guided onboarding) vs No-training (self-guided) for \\~1 month. Part B is a 10-month longitudinal home-use clinical performance component comparing WearME-Pro predicted lung function to daily handheld spirometry. Participants may enroll in Part A, Part B, or both (Part A first if both).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-04-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean difference in FEV1 (L) between WearME-Pro predicted lung function and handheld spirometer', 'timeFrame': 'Up to 10 months (daily paired measures through Month 10)', 'description': '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.'}, {'measure': 'Mean difference in FVC (L) between WearME-Pro predicted lung function and handheld spirometer', 'timeFrame': 'Up to 10 months (daily paired measures through Month 10)', 'description': 'Agreement will be assessed using paired daily measurements of FVC collected during home use. The outcome will be summarized as the mean difference (WearME-Pro - handheld spirometer) in FVC (liters) across paired measurements.'}, {'measure': 'Mean difference in FEV1/FVC (unitless ratio) between WearME-Pro predicted lung function and handheld spirometry', 'timeFrame': 'Up to 10 months (daily paired measures through Month 10)', 'description': 'Agreement will be assessed using paired daily measurements of FEV1/FVC collected during home use. The outcome will be summarized as the mean difference (WearME-Pro - handheld spirometer) in FEV1/FVC ratio across paired measurements.'}, {'measure': 'System Usability Scale (SUS) total score (0-100)', 'timeFrame': 'End of Part A (Week 4; up to 1 month)', 'description': 'SUS questionnaire to assess usability for intended users in Part A (human factors/usability). Target mean SUS \\> 85 over the usability period.'}, {'measure': 'Monthly adherence rate to planned daily WearME-Pro sessions (%)', 'timeFrame': 'Months 1-9', 'description': 'Adherence will be summarized as the percent of planned days per month with a completed WearME-Pro session with valid data, with a target of ≥85% monthly adherence during the longitudinal component.'}], 'secondaryOutcomes': [{'measure': 'Single Ease Question (SEQ) score (7-point Likert scale)', 'timeFrame': 'Part A (Baseline/Onboarding through Week 4; up to 1 month)', 'description': 'SEQ ratings collected during Part A to assess perceived ease of use for critical tasks (higher score indicates easier).'}, {'measure': 'Critical task success rate during Part A (%)', 'timeFrame': 'Part A (Baseline/Onboarding through Week 4; up to 1 month)', 'description': 'Proportion of participants who successfully complete predefined critical tasks during Part A (reported as percent successful).'}, {'measure': 'Number of use errors during critical tasks in Part A', 'timeFrame': 'Part A (Baseline/Onboarding through Week 4; up to 1 month)', 'description': 'Count of observed use errors during predefined critical tasks performed in Part A.'}, {'measure': 'Mean difference in heart rate (bpm) between WearME-Pro and Cardea SOLO ECG patch', 'timeFrame': 'Up to 48 hours at Baseline and up to 48 hours at End of Study (Month 10)', 'description': 'Heart rate agreement will be summarized as the mean difference (WearME-Pro - Cardea SOLO) in beats per minute (bpm) during the monitoring windows in the optional subset.'}, {'measure': 'Respiratory rate (breaths per minute) measured by WearME-Pro', 'timeFrame': 'Up to 10 months (during daily sessions through Month 10)', 'description': 'Respiratory rate measured by WearME-Pro during daily home-use sessions; summarized as the mean respiratory rate (breaths/min) during each session, and averaged across sessions through Month 10.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['COPD', 'Wearable sensor', 'WearME', 'Remote monitoring', 'Home use', 'Lung function', 'Spirometry', 'FEV1', 'FVC', 'FEV1/FVC', 'Usability', 'Human factors', 'Adherence', 'Mobile application', 'Patch'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 21 years or older, either sex.\n* Diagnosed with COPD per GOLD criteria (GOLD 2025): post-bronchodilator FEV1/FVC \\< 0.70; stratified by post-bronchodilator FEV1% predicted (severity strata).\n* On stable maintenance therapy for at least 2 months (no COPD medication class changes or dose escalations).\n* Current, former, or never smoker (smoking history collected but not an eligibility requirement).\n* Able to perform activities of daily living and complete study procedures (e.g., sit upright and perform spirometry maneuvers).\n* Able and willing to provide informed consent.\n* Not currently enrolled in another investigational device study that could confound outcomes (prior WearME-Basic Phase I participation permitted if completed and not concurrent).\n* Owns a compatible smartphone/tablet or willing to use a loaner device.\n* Willing to wear WearME-Pro patch and perform daily handheld spirometry throughout the study.\n* Optional subset only: willing to wear Cardea SOLO ECG patch for up to 24-48 hours at baseline and end of study if selected.\n\nExclusion Criteria:\n\n* COPD exacerbation within past 6 weeks requiring systemic corticosteroids and/or antibiotics, urgent/ED visit, or hospitalization.\n* Known allergy or severe skin sensitivity to medical adhesives, or dermatologic conditions at intended placement sites.\n* Any condition that, in the investigator's opinion, may interfere with compliance or safety.\n* Inability or unwillingness to perform daily spirometry or to use the mobile app."}, 'identificationModule': {'nctId': 'NCT07430605', 'acronym': 'WearME-Pro', 'briefTitle': 'WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).', 'organization': {'class': 'INDUSTRY', 'fullName': 'LASARRUS Clinic and Research Center'}, 'officialTitle': 'WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor)', 'orgStudyIdInfo': {'id': 'LAS-02/03-WZ-024'}, 'secondaryIdInfos': [{'id': '4R44HL172444', 'link': 'https://reporter.nih.gov/quickSearch/4R44HL172444', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WearME-Pro Patch System + Guided Training', 'description': 'Participants with COPD use the WearME-Pro patch system at home and complete scheduled sessions plus daily handheld spirometry. Participants receive guided onboarding/training on device setup, app workflow, and patch placement. Usability, adherence, and agreement between WearME-Pro predicted lung function and reference spirometry are evaluated. WearME-Pro outputs are investigational and not used for clinical decision-making.', 'interventionNames': ['Device: WearME-Pro Patch System', 'Device: FDA-cleared handheld spirometer (reference comparator)', 'Device: Cardea SOLO ECG patch (optional subset; exploratory HR reference)']}, {'type': 'EXPERIMENTAL', 'label': 'WearME-Pro Patch System (Self-Guided / No Training)', 'description': 'Participants with COPD use the WearME-Pro patch system at home and complete scheduled sessions plus daily handheld spirometry. Participants follow self-guided instructions without guided training. Usability, adherence, and agreement between WearME-Pro predicted lung function and reference spirometry are evaluated. WearME-Pro outputs are investigational and not used for clinical decision-making.', 'interventionNames': ['Device: WearME-Pro Patch System', 'Device: FDA-cleared handheld spirometer (reference comparator)', 'Device: Cardea SOLO ECG patch (optional subset; exploratory HR reference)']}], 'interventions': [{'name': 'WearME-Pro Patch System', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['WearME-Pro Patch System (Self-Guided / No Training)', 'WearME-Pro Patch System + Guided Training']}, {'name': 'FDA-cleared handheld spirometer (reference comparator)', 'type': 'DEVICE', 'description': 'Daily handheld spirometry collected at home to provide reference standards for paired comparisons with WearME-Pro predicted lung function (FEV1, FVC, FEV1/FVC).', 'armGroupLabels': ['WearME-Pro Patch System (Self-Guided / No Training)', 'WearME-Pro Patch System + Guided Training']}, {'name': 'Cardea SOLO ECG patch (optional subset; exploratory HR reference)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['WearME-Pro Patch System (Self-Guided / No Training)', 'WearME-Pro Patch System + Guided Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'contacts': [{'name': 'Edward S Chen, MD', 'role': 'CONTACT', 'email': 'echen3@jh.edu', 'phone': '(410) 550-5864'}, {'name': 'Tianzhi Mao', 'role': 'CONTACT', 'email': 'tmao2@jhmi.edu', 'phone': '(410)502-5819'}, {'name': 'Adrian S Dobs, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21230', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'contacts': [{'name': 'Lloyd Emokpae, PhD', 'role': 'CONTACT', 'email': 'lloyd.emokpae@lasarrus.com', 'phone': '301-388-5453'}, {'name': 'Roland N Emokpae, Jr., MD', 'role': 'CONTACT', 'email': 'roland.emokpae.jr@lasarrus.com', 'phone': '301-388-8067'}, {'name': 'Lia Mandavalli, DO', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'LASARRUS Clinic and Research Center Inc.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21801', 'city': 'Salisbury', 'state': 'Maryland', 'country': 'United States', 'contacts': [{'name': 'Robert T Chasse, MD', 'role': 'CONTACT', 'email': 'Robert.Chasse@tidalhealth.org', 'phone': '410-543-7722'}, {'name': 'Robert Joyner, PhD., RRT', 'role': 'CONTACT', 'email': 'Robert.Joyner@tidalhealth.org', 'phone': '410-543-7017'}, {'name': 'Sandra Fetko', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'TidalHealth', 'geoPoint': {'lat': 38.36067, 'lon': -75.59937}}], 'centralContacts': [{'name': 'Lloyd E Emokpae, PhD.', 'role': 'CONTACT', 'email': 'lloyd.emokpae@lasarrus.com', 'phone': '301-388-5453'}, {'name': 'Roland N Emokpae, Jr., MD', 'role': 'CONTACT', 'email': 'roland.emokpae.jr@lasarrus.com', 'phone': '301-388-8067'}], 'overallOfficials': [{'name': 'Edward Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LASARRUS Clinic and Research Center', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'Tidalhealth', 'class': 'UNKNOWN'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}