Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 11:35 PM
Study NCT ID:
NCT03543293
Status:
UNKNOWN
Last Update Posted:
2018-06-01
First Post:
2018-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Imaging Perilymphatic Fistulas After Barotrauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014717', 'term': 'Vertigo'}, {'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-31', 'studyFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2018-05-31', 'lastUpdatePostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of perilymphatic fistula', 'timeFrame': '1 hour after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['perilymphatic fistulas', 'magnetic resonance imaging (MRI)', 'surgery', 'round window', 'vertigo', 'tinnitus', 'cophosis'], 'conditions': ['Perilymphatic Fistulas']}, 'descriptionModule': {'briefSummary': 'Our objective is to validate the CT / MRI combination of non-injected rock for the rapid positive diagnosis of perilymphatic fistulas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient having undergone a rock scan or MRI of the middle ear at the Strasbourg University Hospital with surgical confirmation of the diagnosis (or reversal)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18\n* Clinical suspicion of perilymphatic fistula\n* Patient having undergone a rock scan or MRI of the middle ear at the Strasbourg University Hospital with surgical confirmation of the diagnosis (or reversal)\n\nExclusion Criteria:\n\n\\- Refusal of the patient to participate in the study'}, 'identificationModule': {'nctId': 'NCT03543293', 'briefTitle': 'Imaging Perilymphatic Fistulas After Barotrauma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Fast and Accurate Diagnosis of an Oval or Round Window Perilymphatic Fistula on CT and MRI, Without Injection, on 101 Patients With Surgical Confirmation', 'orgStudyIdInfo': {'id': '6807'}}, 'contactsLocationsModule': {'locations': [{'zip': '67098', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Francis VEILLON, MD, PhD', 'role': 'CONTACT', 'phone': '33 3 88 12 78 65'}, {'name': 'Aïna VENKATASAMY, MD', 'role': 'CONTACT', 'email': 'aina.venkatasamy@chru-strasbourg.fr', 'phone': '33 3 88 12 78 65'}, {'name': 'Francis VEILLON, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Aïna VENKATASAMY, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service Imagerie 1', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Francis VEILLON, MD, PhD', 'role': 'CONTACT', 'email': 'Francis.veillon@chru-strasbourg.fr', 'phone': '33 3 88 12 78 65'}, {'name': 'Aïna VENKATASAMY, MD', 'role': 'CONTACT', 'email': 'aina.venkatasamy@chru-strasbourg.fr', 'phone': '33 3 88 12 78 65'}], 'overallOfficials': [{'name': 'Francis VEILLON, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Strasbourg, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}