Nctid:
NCT06614218
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000005901", "term"=>"Glaucoma"}, {"id"=>"D000005902", "term"=>"Glaucoma, Open-Angle"}], "ancestors"=>[{"id"=>"D000009798", "term"=>"Ocular Hypertension"}, {"id"=>"D000005128", "term"=>"Eye Diseases"}], "browseLeaves"=>[{"id"=>"M9013", "name"=>"Glaucoma", "asFound"=>"Glaucoma", "relevance"=>"HIGH"}, {"id"=>"M9014", "name"=>"Glaucoma, Open-Angle", "asFound"=>"Open Angle Glaucoma", "relevance"=>"HIGH"}, {"id"=>"M10024", "name"=>"Hypertension", "relevance"=>"LOW"}, {"id"=>"M12731", "name"=>"Ocular Hypertension", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-11-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-01-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "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"=>40.18111, "lon"=>44.51361}}], "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"}}}}
