Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT00794105
Status:
UNKNOWN
Last Update Posted:
2008-11-19
First Post:
2008-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observation of Gas Exchange in the Middle Ear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009085', 'term': 'Mucopolysaccharidosis IV'}], 'ancestors': [{'id': 'D009083', 'term': 'Mucopolysaccharidoses'}, {'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D017520', 'term': 'Mucinoses'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'lastUpdateSubmitDate': '2008-11-18', 'studyFirstSubmitDate': '2008-11-18', 'studyFirstSubmitQcDate': '2008-11-18', 'lastUpdatePostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creation of air bubbles.', 'timeFrame': 'one year.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gas', 'Middle ear'], 'conditions': ['Normal Middle Ears.', 'Otitis Media Ears.']}, 'descriptionModule': {'briefSummary': 'Observation of fluid behavior over a perforated eardrum.\n\nA comparison of the behavior of the gas in normal vs. different kinds of otitis media ears.', 'detailedDescription': "Fluid present in middle ears is observed during the regular treatment of patients.\n\nThe observation in made during the treatment and not as an additional activity. The fluid is either a steroids solution or sterile normal saline or ear's mucus discharge, all in perforated eardrums, either as a part of their intra-tympanic treatment for sudden hearing loss, or traumatic perforation \\[considered as the normal ears\\] compared to otitis media ears.\n\nThe observation is made on bubble formation over the perforation. The time length of the inspection is about 1 minute, under the microscope, during the treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated as a routine treatment in the outpatient or patients admitted for treatment of sudden hearing loss.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having perforated eardrum.\n\nExclusion Criteria:\n\n* Non cooperative patients.'}, 'identificationModule': {'nctId': 'NCT00794105', 'briefTitle': 'Observation of Gas Exchange in the Middle Ear', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'orgStudyIdInfo': {'id': 'cohenmed.CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal ears'}, {'label': 'Otitis media ears.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91031', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Otolaryngology Dept., Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'David Cohen, MD', 'role': 'CONTACT', 'email': 'cohendv@netvision.net.il', 'phone': '+ 972 50 8685888'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'David Cohen, MD', 'oldOrganization': 'Shaare Zedek Medical Center'}}}}