Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT04784169
Status:
UNKNOWN
Last Update Posted:
2021-03-05
First Post:
2021-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002559', 'term': 'Cerebrospinal Fluid Rhinorrhea'}], 'ancestors': [{'id': 'D065634', 'term': 'Cerebrospinal Fluid Leak'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000086722', 'term': 'Rhinorrhea'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-03', 'studyFirstSubmitDate': '2021-01-08', 'studyFirstSubmitQcDate': '2021-03-03', 'lastUpdatePostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Cerebrospinal Fluid (CSF) Leak', 'timeFrame': '1month'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Postoperative Complications', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CSF Leakage']}, 'descriptionModule': {'briefSummary': 'Limited literature has been reported the use of free middle turbinate flap during an endoscopic approach to treat cerebrospinal fluid (CSF) leak, and the results were inconclusive. The overall purpose of this study was to assess the efficacy and safety of free middle turbinate flap in reparing CSF leak during an endoscopic approach.', 'detailedDescription': 'Cerebrospinal fluid (CSF) rhinorrhea results from an abnormal communication between the sinonasal cavity and the subarachnoid space. It may occur spontaneously or secondary to accidental or iatrogenic trauma. CSF leak is a potentially devastating condition that can lead to ascending meningitis, pneumocephalus, and intracranial abscess. Surgical repair is recommended for most patients with CSF leaks to prevent the potential sequelae.\n\nMultiple graft materials have been employed in the approach, including temporalis fascia, middle turbinate flap, fascia lata, fat, free cartilage or bone, vascularized nasoseptal flap and acellular skin grafts. Among these options, vascular nasoseptal flaps are the most popular materials at present. Limited literature has been reported the use of free middle turbinate flap during an endoscopic approach to treat CSF rhinorrhea, and the results were inconclusive. There were a large number of cases using free middle turbinate flap for CSF rhinorrhea repair in our institution. The purpose of this study was to determine the efficacy and safety of the free middle turbinate flap for repair of CSF rhinorrhea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing repairing of CSF leak under transsphenoidal approach\n* Dural defect smaller than 1cm\n* No extensive arachnoid dissection\n* No dissection into a ventricle or cistern\n\nExclusion Criteria:\n\n* High flow CSF leak'}, 'identificationModule': {'nctId': 'NCT04784169', 'briefTitle': 'Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak', 'orgStudyIdInfo': {'id': '20210086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'free middle turbinate flap group', 'description': 'A free middle turbinate flap is used to repair the leakage', 'interventionNames': ['Device: free middle turbinate flap']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vascularized nasoseptal flap', 'description': 'A vascularized nasoseptal flap is used to repair the leakage', 'interventionNames': ['Device: vascularized nasoseptal flap']}], 'interventions': [{'name': 'free middle turbinate flap', 'type': 'DEVICE', 'description': 'Repairing low flow leak using free middle turbinate flap', 'armGroupLabels': ['free middle turbinate flap group']}, {'name': 'vascularized nasoseptal flap', 'type': 'DEVICE', 'description': 'Repairing low flow leak using fascia lata', 'armGroupLabels': ['vascularized nasoseptal flap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'GAO HUI', 'role': 'CONTACT', 'phone': '+8613476850638'}], 'facility': 'GAO HUI', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Qiangping Wang, MD', 'role': 'CONTACT', 'email': 'kouxiangtang7595@163.com', 'phone': '+8613476850638'}, {'name': 'Qiangping Wang', 'role': 'CONTACT', 'email': 'kouxiangtang7595@163.com'}], 'overallOfficials': [{'name': 'GAO HUI', 'role': 'STUDY_CHAIR', 'affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Qiangping Wang', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}