Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-31 @ 8:21 PM
Study NCT ID:
NCT00270660
Status:
UNKNOWN
Last Update Posted:
2006-11-30
First Post:
2005-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Clinicopathologic Behaviour of the Different Types of Unsafe Chronic Otitis Media
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002781', 'term': 'Cholesteatoma'}], 'ancestors': [{'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D006309', 'term': 'Hearing'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000084323', 'term': 'Vestibulocochlear Physiological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 192}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-12', 'completionDateStruct': {'date': '2005-12'}, 'lastUpdateSubmitDate': '2006-11-29', 'studyFirstSubmitDate': '2005-12-23', 'studyFirstSubmitQcDate': '2005-12-23', 'lastUpdatePostDateStruct': {'date': '2006-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-28', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['retraction pockets ear', 'unsafe otitis media', 'otitis media complications'], 'conditions': ['Chronic Otitis Media', 'Cholesteatoma']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to study the clinicopathologic behaviour of the 3 dangerous types of chronic otitis media that are prone for complications. In which type are the complications more common? Which type gives rise to more hearing loss? How does the disease process in the 3 types evolve? should the 3 types of otitis media be managed differently?', 'detailedDescription': 'Design: prospective cross sectional study setting: tertiary referral medical college hospital No of groups: 3 group 1: primary acquired atticoantral disease group 2: secondary acquired atticoantral disease group 3: mixed atticoantral disease\n\nInterventions:\n\n1. Diagnostic nasal endoscopy\n2. Eustachian tube function tests\n3. Pure tone audiometry\n4. biopsy of middle ear mucosa\n5. culture and sensitivity of ear discharge'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:1. Atticoantral chronic otitis media 2. complicated unsafe otitis media 3. Otitis media with cholesteatoma, polyp, granulation tissue 4. Ear with retraction pockets leading to attic -\n\nExclusion Criteria:\n\n1. tubotympanic otitis media alone\n2. otitis media with effusion\n3. Acute otitis media -'}, 'identificationModule': {'nctId': 'NCT00270660', 'briefTitle': 'A Study of the Clinicopathologic Behaviour of the Different Types of Unsafe Chronic Otitis Media', 'organization': {'class': 'OTHER', 'fullName': 'Karnataka Institute of Medical Sciences'}, 'officialTitle': 'A Cross Sectional Study of Clinicopathologic Behaviour of Primary, Secondary and Mixed Types of Atticoantral Chronic Otitis Media', 'orgStudyIdInfo': {'id': 'M06a/2003-04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'biopsy, audiometry, ET function test, ear swab culture, DNE', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '580021', 'city': 'Hubli', 'state': 'Karnataka', 'country': 'India', 'facility': 'Department of ENT, KIMS', 'geoPoint': {'lat': 17.58662, 'lon': 76.51148}}], 'overallOfficials': [{'name': 'Vikram K Bhat, MS, DNB.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karnataka Institute of Medical Sciences, Hubli, India'}, {'name': 'Khaja Naseeruddin, MS, DLO.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vijayanagar Institute of Medical Sciences, Bellary, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karnataka Institute of Medical Sciences', 'class': 'OTHER'}}}}