Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-26 @ 1:09 AM
Study NCT ID:
NCT05497934
Status:
WITHDRAWN
Last Update Posted:
2024-08-21
First Post:
2022-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Glycerol as an Optical Clearing Agent for Visualization of the Middle Ear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092163', 'term': 'Tympanosclerosis'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005990', 'term': 'Glycerol'}], 'ancestors': [{'id': 'D000073999', 'term': 'Triose Sugar Alcohols'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All subjects will undergo OCT and conventional endoscopic imaging before topical application of glycerol to the tympanic membrane, after topical application of glycerol to the tympanic membrane and after rinsing the tympanic membrane with saline.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No response from initial letter or expiry email- closed by REB office', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2022-08-10', 'studyFirstSubmitQcDate': '2022-08-10', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in optical attenuation rate of the tympanic membrane', 'timeFrame': '20 minutes', 'description': 'Change in optical attenuation rate (dB/mm) of the tympanic membrane between the pre-treatment and post-treatment conditions'}], 'secondaryOutcomes': [{'measure': 'Change in acoustic mobility of the umbo', 'timeFrame': '20 minutes', 'description': 'Change in the mobility (mm/s/Pa) of the umbo between pre- and post-treatment conditions'}, {'measure': 'Change in B-mode signal-to-noise ratio of the cochlear promontorium', 'timeFrame': '20 minutes', 'description': 'Change in the B-mode signal-to-noise ratio for a region of interest on the cochlear promontorium distal to the tympanic membrane between pre- and post-treatment conditions'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tympanosclerosis', 'Thickened Ears', 'Healthy', 'Surgery']}, 'descriptionModule': {'briefSummary': 'This study will examine the improvement in middle ear optical coherence tomography imaging from the topical application of glycerol to the tympanic membrane in normal, opaque and post-operative ears', 'detailedDescription': 'This study will explore whether the utility of Optical Coherence Tomography (OCT) in otology patients can be enhanced through the application of topical glycerol as an optical clearing agent in patients with normal, opaque and post operative tympanic membranes. In each group of subjects, a comparison will be made between OCT images obtained before and after the topical application of glycerol to the tympanic membrane and following washout with saline. Images will also be assessed for their diagnostic utility as determined by the visibility of key structures and the change in middle ear mobility caused by glycerol absorption in the tympanic membrane.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thickened tympanic membrane (e.g. due to fibrosis) x10\n* Tympanosclerosis of the tympanic membrane x10\n* History of middle ear surgery with partial or total ossicular replacement prosthesis and cartilage tympanoplasty x10\n* History of cartilage tympanoplasty without prosthesis implantation x10\n* Normal tympanic membrane without history of middle ear disease x10\n\nExclusion Criteria:\n\n* Narrow or stenotic external auditory canal that prevents visualization of the tympanic membrane\n* Mobility disorder that prevents patient from remaining still during imaging\n* Perforation of the tympanic membrane\n* Open sores or infections of the external auditory canal'}, 'identificationModule': {'nctId': 'NCT05497934', 'briefTitle': 'The Effects of Glycerol as an Optical Clearing Agent for Visualization of the Middle Ear', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'The Effects of Glycerol as an Optical Clearing Agent for Visualization of the Middle Ear', 'orgStudyIdInfo': {'id': '1028201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Subjects will be imaged with OCT and endoscopy before treatment of the tympanic membrane with topical glycerol, after treatment of the tympanic membrane with topical glycerol and after rinsing the tympanic membrane with saline', 'interventionNames': ['Drug: Glycerol']}], 'interventions': [{'name': 'Glycerol', 'type': 'DRUG', 'otherNames': ['Glycerin(e)'], 'description': 'In this study, 99.5% pure glycerol will be used as an optical clearing agent. The glycerol will be applied topically to the tympanic membrane.', 'armGroupLabels': ['Treatment arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David P Morris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Scotia Health Authority'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Results of trial will be published in a journal article'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dalhousie University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}