Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-04 @ 2:33 PM
Study NCT ID:
NCT03751904
Status:
WITHDRAWN
Last Update Posted:
2019-01-29
First Post:
2018-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor is no longer pursuing the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-25', 'studyFirstSubmitDate': '2018-11-15', 'studyFirstSubmitQcDate': '2018-11-21', 'lastUpdatePostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': 'Subjects will be assessed for adverse events through study completion, an average of 1 day', 'description': 'The safety of the Acousticare device will be assessed by reviewing adverse events in all patients enrolled in the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure，Congestive']}, 'descriptionModule': {'briefSummary': 'AcoustiCareTM is a non-invasive clinical tool used for the detection of intracardiac pressures using heart sounds in patients with heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects between the ages of 18 - 80 years\n2. Willing and able to sign informed consent form\n3. Normal subjects without a history of heart disease who are recruited from the surrounding community\n4. Subjects with heart failure undergoing treatment in a hospital setting\n\nExclusion Criteria:\n\n1. Hemodynamic instability (Systolic BP\\>180 or \\<90 and Diastolic BP\\>90 and \\<60)\n2. Acute coronary syndrome\n3. Prior heart transplant recipients\n4. Subjects who are pacemaker dependent\n5. Severe obesity (body mass index \\> 40 kg/m2)\n6. Subjects who are pregnant'}, 'identificationModule': {'nctId': 'NCT03751904', 'briefTitle': 'Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™', 'organization': {'class': 'OTHER', 'fullName': 'Signature Medical, Inc.'}, 'officialTitle': 'Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™', 'orgStudyIdInfo': {'id': 'SIG-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'AcoustiCare', 'description': 'Single Arm', 'interventionNames': ['Device: AcoustiCare']}], 'interventions': [{'name': 'AcoustiCare', 'type': 'DEVICE', 'description': 'Electronic stethoscope', 'armGroupLabels': ['AcoustiCare']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Signature Medical, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}