Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06614218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-10
First Post:
2024-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MIMS® Retrospective Chart Review
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2024-09-24', 'studyFirstSubmitQcDate': '2024-09-25', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in IOP from medicated baseline at 12 months post-MIMS® surgery', 'timeFrame': 'Medicated baseline at 12 months post-MIMS® surgery'}, {'measure': 'Change in the number of topical IOP-lowering medications from medicated baseline at 12 months post-MIMS® surgery', 'timeFrame': 'Medicated baseline at 12 months post-MIMS® surgery'}, {'measure': 'Success rate at 12 months post-MIMS® surgery', 'timeFrame': '12 months post-MIMS® surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polypharmacy', 'Intraocular Pressure', 'MIMS', 'Minimally Invasive Glaucoma Surgery', 'MIGS', 'MTMT', 'Trabeculectomy', 'Sclerostomy'], 'conditions': ['Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'This is a post-market clinical follow-up, retrospective chart review of MIMS® surgical procedures conducted during time period between Sep 2023 and May 2025.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of subjects of Armenian descent that were treated with the MIMS® Device as a standalone procedure between 27 Sep 2023 and 30 April 2024.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Eye treated with MIMS® Device as a standalone procedure\n2. MIMS® surgery was performed between 27 Sep 2023 and 30 April 2024'}, 'identificationModule': {'nctId': 'NCT06614218', 'briefTitle': 'MIMS® Retrospective Chart Review', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanoculis Ltd'}, 'officialTitle': 'Minimally Invasive Micro Sclerostomy (MIMS®) Retrospective Chart Review', 'orgStudyIdInfo': {'id': 'MMS-EEU-9'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MIMS Surgery Cohort', 'description': 'This cohort consists subjects treated with MIMS® Device as a standalone procedure during time period (27 Sep 2023 - 31 May 2025), and with documented post-operative follow-up available in the medical charts.', 'interventionNames': ['Device: Minimally Invasive Micro Sclerostomy']}], 'interventions': [{'name': 'Minimally Invasive Micro Sclerostomy', 'type': 'DEVICE', 'otherNames': ['MIMS'], 'description': 'The MIMS® procedure uses the proprietary MIMS® device, which creates a sclerostomy in the eye.', 'armGroupLabels': ['MIMS Surgery Cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yerevan', 'country': 'Armenia', 'facility': 'S. Malayan Eye Center', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}], 'centralContacts': [{'name': 'Khan Lau, OD', 'role': 'CONTACT', 'email': 'khan@sanoculis.com', 'phone': '8082862666'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanoculis Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}