Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-20 @ 1:33 PM
Study NCT ID:
NCT06577857
Status:
RECRUITING
Last Update Posted:
2024-09-26
First Post:
2024-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inferonasal MIMS® Procedure: Long-Term Follow-Up Extension Study
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': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure Change (Baseline to 24 months)', 'timeFrame': 'Baseline to 24 months post-MIMS® surgery', 'description': 'Change in IOP from medicated baseline to 24 months post-MIMS® surgery'}, {'measure': 'Intraocular Pressure Change (Baseline to 30 months)', 'timeFrame': 'Baseline to 30 months post-MIMS® surgery', 'description': 'Change in IOP from medicated baseline to 30 months post-MIMS® surgery'}, {'measure': 'Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 24 Months)', 'timeFrame': 'Medicated baseline to 24 months post-MIMS® surgery', 'description': 'Change in the number of topical IOP-lowering medications from medicated baseline to 24 months post-MIMS® surgery'}, {'measure': 'Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 30 Months)', 'timeFrame': 'Medicated baseline to 30 months post-MIMS® surgery', 'description': 'Change in the number of topical IOP-lowering medications from medicated baseline to 30 months post-MIMS® surgery'}, {'measure': 'Surgery Success Rate (24 months)', 'timeFrame': '24 months post-MIMS® surgery', 'description': 'Success rate 24 months post-MIMS® surgery'}, {'measure': 'Surgery Success Rate (30 months)', 'timeFrame': '30 months post-MIMS® surgery', 'description': 'Success rate 30 months post-MIMS® surgery'}], 'secondaryOutcomes': [{'measure': 'Postoperative Complication Safety Outcomes', 'timeFrame': 'Baseline to 30 months post-MIMS® surgery', 'description': 'Late (greater than 12 months) postoperative complications'}, {'measure': 'Interventional Safety Outcomes', 'timeFrame': 'Baseline to 30 months post-MIMS® surgery', 'description': 'Late (greater than 12 months) postoperative interventions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intraocular Pressure', 'MIMS', 'Inferonasal', 'Minimally Invasive Glaucoma Surgery', 'Trabeculectomy', 'Sclerostomy', 'MIGS'], 'conditions': ['Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'A long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior MIMS® inferonasal surgery, in continuation of the previous clinical investigation with the MIMS® Device (MMS-EEU-5).'}, '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 underwent the MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Subject who underwent MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment'}, 'identificationModule': {'nctId': 'NCT06577857', 'briefTitle': 'Inferonasal MIMS® Procedure: Long-Term Follow-Up Extension Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanoculis Ltd'}, 'officialTitle': 'Minimally Invasive Micro Sclerostomy (MIMS®) Inferonasal Procedure: Long-Term Follow-Up Extension Study', 'orgStudyIdInfo': {'id': 'MMS-EEU-8'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Inferonasal MIMS Surgery Cohort', 'description': 'Cohort that includes subjects that have undergone the MIMS® inferonasal surgery.', 'interventionNames': ['Device: Inferonasal Minimally Invasive Micro Sclerostomy']}], 'interventions': [{'name': 'Inferonasal Minimally Invasive Micro Sclerostomy', 'type': 'DEVICE', 'otherNames': ['Inferonasal MIMS'], 'description': 'The Inferonasal MIMS® procedure uses the proprietary MIMS® device, which creates a sclerostomy in the inferonasal quadrant of the eye.', 'armGroupLabels': ['Inferonasal MIMS Surgery Cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Lilit A Voskanyan, MD', 'role': 'CONTACT', 'phone': '+374-10-34-49-44'}], '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'}}}}