Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT05876533
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-31
First Post:
2023-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
R&D Study to Evaluate Cordio's Usability and to Collect Patient Speech Utterances
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-30', 'studyFirstSubmitDate': '2023-04-23', 'studyFirstSubmitQcDate': '2023-05-24', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Usability success defined as: 1.Total and individual usability score of ≥3 in the usability questionnaire in ≥80% of the users.', 'timeFrame': '2 years', 'description': 'The used scale is: Usability questionnaire for the Cordio HearO™ App. This Usability questionnaire is a subjective evaluation based on Likert score of device user satisfaction.\n\nMaximum value for each item: 5 Minimum value for each item: 1 Higher scores means a better outcome'}, {'measure': 'Patient Usability success defined as: 2. Total Compliance', 'timeFrame': '2 Years', 'description': 'The total compliance will be determined by the total number of recording days. Success will be considered if total average compliance of 70 % of all days.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['CHF'], 'conditions': ['Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'To determine the usability and technical aspects of Cordio HearO™', 'detailedDescription': 'The system (including App and server) will be tested under simulated use conditions with representative users to identify potential changes required to the application user interface, to improve user performance and satisfaction, and to inform future design options.\n\nThe recordings data will also be used for algorithm improvement'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult clinical stable patients with NYHA II-IVa (ambulatory)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major inclusion Criteria:\n\n1. Adults patients\n2. Diagnosed with Symptomatic Chronic Heart Failure \\[NYHA II-IVa (ambulatory)\\]\n3. At least one of the following:\n\n 1. One ADHF hospitalization in the last 12 months\n 2. One unplanned IV/SC diuretic administration in the last 6 months\n 3. Two unplanned IV/SC diuretic administration in the last 12 months\n 4. NTProBNP \\>500 pg/ml or BNP\\*\\> 150 pg/ml at screening visit\n4. Clinically stable HF\n5. Willing to participate as evidenced by signing the written informed consent.\n6. Male or non-pregnant female patient (pre-menopausal women will confirm verbally).\n\nMajor exclusion Criteria:\n\n1. Not able to read in Hebrew, Russian, Arabic, English and/or Spanish.\n2. Unable to comply with daily use of the App\n3. Major cardiovascular event\n4. Had a Cardiac Resynchronization Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.\n5. Has estimated Glomerular Filtration Rate (eGFR) \\< 30 ml/min/1.73 meter square (Cockroft-Gault formula).\n6. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.'}, 'identificationModule': {'nctId': 'NCT05876533', 'briefTitle': "R&D Study to Evaluate Cordio's Usability and to Collect Patient Speech Utterances", 'organization': {'class': 'INDUSTRY', 'fullName': 'Cordio Medical'}, 'officialTitle': 'An Observational, Retrospective, Single-arm, Open US and Israel Study , for Usability Assessment and Algorithm, Development of the Cordio HearO™ Systeam', 'orgStudyIdInfo': {'id': 'CLN0016'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cordio HearO', 'type': 'DEVICE', 'description': 'Cordio HearO is a software medical device that remotely monitors Congestive Heart Failure (CHF) patients by detecting changes in the patients\' recorded voice relative to a baseline. The system is comprised of a mobile application (or "app") that is deployed on a mobile platform, and a web-based portal that enables caregivers to manage their patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06074', 'city': 'South Windsor', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Kurker Family Medicine', 'geoPoint': {'lat': 41.82371, 'lon': -72.6212}}, {'zip': '33904', 'city': 'Cape Coral', 'state': 'Florida', 'country': 'United States', 'facility': 'C&R Research Services', 'geoPoint': {'lat': 26.56285, 'lon': -81.94953}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'C&R Research Services', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33183', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'C&R Research Services', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '31024', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Lake County Med Grp', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'city': 'Ashkelon', 'country': 'Israel', 'facility': 'Barzilai Medical Center- Cardiology', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}, {'city': 'Beersheba', 'country': 'Israel', 'facility': "Heart Failure Clinic - Clallit Be'er Sheva", 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center - Cardiology- CHF', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Ronit Haviv, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cordio Medical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cordio Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}