Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-22 @ 12:06 PM
Study NCT ID:
NCT06542367
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-13
First Post:
2024-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C518955', 'term': 'TachoSil'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2024-08-04', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'closure of tympanic membrane perforation', 'timeFrame': '1 year following the procedure', 'description': 'the effectiveness of the tympanoplasty using far graft and "Tachosil" will be evaluated - whether close of tympanic membrane perforation occured.'}], 'secondaryOutcomes': [{'measure': 'Hearing results following tympanoplasty - Speech recognition threshold', 'timeFrame': '1 year following the procedure', 'description': 'SRT (Speech recognition threshold) in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.'}, {'measure': 'Hearing results following tympanoplasty - Pure Tone Average', 'timeFrame': '1 year following the procedure', 'description': 'PTA air and PTA bone (Pure Tone Average) in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.'}, {'measure': 'Hearing results following tympanoplasty - air bone gap.', 'timeFrame': '1 year following the procedure', 'description': 'Air-bone gap in dB (Decibel) will be evaluated pre and post tympanoplasty using an audiogram.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tympanoplasty'], 'conditions': ['Tympanic Membrane Perforation']}, 'descriptionModule': {'briefSummary': 'Eligible participants with chronic tympanic membrane perforation (\\>6 month) will be given a detailed description and offered to participate in the study.\n\nthe study investigates the efficacy of trans canal tympanoplasty with local anesthesia using fat pad and "Tachosil". Participants will be followed for 1 year after the procedure with otological examination and successive hearing evaluations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic tympanic membrane perforation (\\>6 months).\n* Central tympanic membrane perforation.\n* Air bone gar of 35 dB or lower at the operated ear.\n* No active otorrhea in the operated ear in the preceding 3 month prior to the procedure.\n* No evidence of a retraction pocket and no suspicion for a cholesteatoma.\n\nExclusion Criteria:\n\n* Known ossicular chain dysfunction\n* The tympanic membrane perforation edges are not accessible/visualized transcanal\n* Pregnancy\n* Allergy to lidocaine'}, 'identificationModule': {'nctId': 'NCT06542367', 'briefTitle': 'Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"', 'orgStudyIdInfo': {'id': '0047-24-EMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcanal tympanoplasty under local anasthesia with fat graft and "Tachosil"', 'description': 'eligibale participatns with chronic tympanic membrane perforation will be offered to participate.\n\nUnder local anesthesia, subcutaneous fat from the neck will be harvested. After that trimming of the perforation edges, planting the fat graft medial to the tympanic membrane and placement of the "Tachosil" on top of the fat graft.\n\ngelfoam is placed lateral to the tympanic membrane fo fill the ear canal. follow-up will be held at 2, 4-6 and 12 month following the procedure, with audiometric and otological evaluation', 'interventionNames': ['Procedure: Tympanoplasty performed under local anesthesia using fat graft and "Tachosil".']}], 'interventions': [{'name': 'Tympanoplasty performed under local anesthesia using fat graft and "Tachosil".', 'type': 'PROCEDURE', 'description': 'Under local anesthesia, subcutaneous fat from the neck will be harvested. After that trimming of the perforation edges, planting the fat graft medial to the tympanic membrane and placement of the "Tachosil" on top of the fat graft.\n\ngelfoam is placed lateral to the tympanic membrane to fill the ear canal. follow-up will be held at 2, 4-6 and 12 months following the procedure, with audiometric and otological evaluation', 'armGroupLabels': ['Transcanal tympanoplasty under local anasthesia with fat graft and "Tachosil"']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'yoni Evgeni Gutkovich, M.D/Ph.D', 'role': 'CONTACT', 'email': 'yonigo@clalit.org.il', 'phone': '+972-46495563'}, {'name': 'Lev Shlizerman, M.D', 'role': 'CONTACT', 'email': 'lev_sh@clalit.org.il', 'phone': '+972-46495563'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Yoni Evgeni Gutkovich', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}