Nctid:
NCT06615661
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "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"=>"M10024", "name"=>"Hypertension", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}, {"id"=>"M9013", "name"=>"Glaucoma", "asFound"=>"Glaucoma", "relevance"=>"HIGH"}, {"id"=>"M9014", "name"=>"Glaucoma, Open-Angle", "asFound"=>"Primary Open Angle Glaucoma", "relevance"=>"HIGH"}, {"id"=>"M12731", "name"=>"Ocular Hypertension", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Eye Diseases", "abbrev"=>"BC11"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>200}, "targetDuration"=>"12 Months", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-08-14", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-10", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-09", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Percent of eyes with intraocular pressure (IOP)reduction ≥20%in comparison with baseline.", "timeFrame"=>"12 month postoperative", "description"=>"Intraocular pressure (IOP) is at least 20% lower than before surgery without additional ocular hypotensive medications or IOP-lowering surgery."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"keywords"=>["Ocular Hypertension, Eye Diseases, Glaucoma, Goniotomy"], "conditions"=>["Primary Open Angle Glaucoma (POAG)"]}, "descriptionModule"=>{"briefSummary"=>"This study enrolls adults with primary open angle glaucoma (POAG) who underwent goniotomy intraocular pressure (IOP)-lowering surgery with the C-Rex Instrument. Patients are consented prior to surgery and followed for 12 months postoperatively. Data regarding IOP, use of glaucoma medications, and any device-related complications are collected during the study time period.", "detailedDescription"=>"This a multicenter, observational real-world evidence study of eligible adults with primary open angle glaucoma (POAG) in whom ab-interno goniotomy surgery with the C-Rex Instrument was performed.\n\nData is collected from the preoperative visit(s) that directly preceded the surgery, the surgical procedure, and post-surgical visits through 12 months postoperatively.\n\nSpecific data collected includes C-Rex Instrument goniotomy surgical details, preoperative and postoperative IOP and use of ocular hypotensive medications, and device-related safety events."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"22 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Eligible participants who underwent IOP-lowering surgical procedures using the C-Rex Instrument to perform ab-interno goniotomy", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Primary open angle glaucoma\n* Goniotomy surgery performed using the C-Rex Instrument\n\nExclusion Criteria:\n\n* History of intraocular surgery within 8 weeks prior to C-Rex surgery\n* Preoperative IOP higher than 33 mmHg\n* Presence of a glaucoma type other than POAG\n* Presence of clinically significant intraocular pathology other than cataract or glaucoma"}, "identificationModule"=>{"nctId"=>"NCT06615661", "acronym"=>"CIRCLE", "briefTitle"=>"A Real-World Evidence Study of Goniotomy with the C-REX™ Instrument in Patients with Primary Open Angle Glaucoma", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Iantrek, Inc."}, "officialTitle"=>"An Observational Real-World Evidence Study of Ab-Interno Goniotomy Performed Using the C-Rex Instrument in Patients with Primary Open Angle Glaucoma", "orgStudyIdInfo"=>{"id"=>"ITR-GON-041"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"C-Rex surgery - combination", "description"=>"C-Rex surgery combined with cataract extraction/intraocular lens (IOL) implantation", "interventionNames"=>["Device: C-Rex Instrument"]}, {"label"=>"C-Rex surgery - standalone", "description"=>"C-Rex surgery as a standalone intervention", "interventionNames"=>["Device: C-Rex Instrument"]}], "interventions"=>[{"name"=>"C-Rex Instrument", "type"=>"DEVICE", "description"=>"The C-Rex Instrument is a manual ophthalmic surgical instrument used for ab interno goniotomy and inner wall trabeculotomy.", "armGroupLabels"=>["C-Rex surgery - combination", "C-Rex surgery - standalone"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"38555", "city"=>"Crossville", "state"=>"Tennessee", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Site 04 Study Coordinator", "role"=>"CONTACT", "email"=>"meganf@ecotn.com", "phone"=>"931-265-5879"}], "facility"=>"CIRCLE Site 04", "geoPoint"=>{"lat"=>35.94896, "lon"=>-85.0269}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Iantrek, Inc.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
