Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT05086718
Status:
UNKNOWN
Last Update Posted:
2021-10-21
First Post:
2021-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media (CSOM) Without Posterior Meatal Flap
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018058', 'term': 'Tympanic Membrane Perforation'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '300 cases of dry perforation CSOM'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2021-09-25', 'studyFirstSubmitQcDate': '2021-10-07', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful air bone gap closure on pure tone audiometry', 'timeFrame': 'Three months', 'description': 'Three months of endoscopic tympanoplasty using composite cartilage-fascia graft, pure tone audiometry will be carried out measuring both air and bone conduction. Successful outcome will be closure of the air bone gap as compared with pre surgery air bone gap.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tympanic Membrane Perforation']}, 'referencesModule': {'references': [{'pmid': '29937839', 'type': 'RESULT', 'citation': 'Akyigit A, Sakallioglu O, Karlidag T. Endoscopic tympanoplasty. J Otol. 2017 Jun;12(2):62-67. doi: 10.1016/j.joto.2017.04.004. Epub 2017 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'Composite Cartilage Perichondrium Graft for tympanoplasty in chronic suppurative otitis media (CSOM) Air Bone Gap (AB Gap) Closure will be taken as successful outcome Endoscopic technique without posterior meatal flap elevation', 'detailedDescription': '300 eligible cases of dry CSOM will under go Composite Cartilage Perichondrium Graft tympanoplasty. Air Bone Gap Closure will be taken as successful outcome. The procedure will employ endoscopic technique without posterior meatal flap elevation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Both genders between 21 to 55 years\n2. Dry chronic suppurative otitis media\n3. Air bone gap between 15 to 25 Deci bel\n\nExclusion Criteria:\n\n1. Discharging ear\n2. Pediatric population\n3. Ossicular Necrosis\n4. Previous ear surgery'}, 'identificationModule': {'nctId': 'NCT05086718', 'briefTitle': 'Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media (CSOM) Without Posterior Meatal Flap', 'organization': {'class': 'OTHER', 'fullName': 'Combined Military Hospital Quetta'}, 'officialTitle': 'Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media Without Posterior Meatal Flap', 'orgStudyIdInfo': {'id': 'RRB/531/CMH Quetta'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'AB Gap Closure', 'description': 'Air Bone gap closure following surgery will be considered as successful outcome', 'interventionNames': ['Other: Endoscopic ear surgery']}], 'interventions': [{'name': 'Endoscopic ear surgery', 'type': 'OTHER', 'description': 'Endoscopic approach without posterior meatal flap elevation will be employed in the ear with dry chronic suppurative otitis media. Tympanoplasty utilizing composite cartilage-fascia graft will be performed. After three months of time period successful outcome will be taken as closure of air bone gap on pure tone audiometry.', 'armGroupLabels': ['AB Gap Closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87300', 'city': 'Quetta', 'state': 'Balochistan', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Zeeshan Ayub, FCPS', 'role': 'CONTACT', 'email': 'zeeshanent@yahoo.com', 'phone': '+923215233648'}, {'name': 'Azeema Ahmed, FCPS', 'role': 'CONTACT', 'email': 'azeemazeeshan1980@gmail.com', 'phone': '+923325222335'}], 'facility': 'CMH Quetta', 'geoPoint': {'lat': 30.18414, 'lon': 67.00141}}], 'centralContacts': [{'name': 'Zeeshan Ayub, FCPS', 'role': 'CONTACT', 'email': 'zeeshanent@yahoo.com', 'phone': '03215233648'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It will depend upon study outcome'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Combined Military Hospital Quetta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor ENT', 'investigatorFullName': 'Dr Zeeshan Ayub', 'investigatorAffiliation': 'Combined Military Hospital Quetta'}}}}