Nctid:
NCT06615713
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007669", "term"=>"Kidney Calculi"}, {"id"=>"D052878", "term"=>"Urolithiasis"}], "ancestors"=>[{"id"=>"D002137", "term"=>"Calculi"}, {"id"=>"D020763", "term"=>"Pathological Conditions, Anatomical"}, {"id"=>"D053040", "term"=>"Nephrolithiasis"}, {"id"=>"D007674", "term"=>"Kidney Diseases"}, {"id"=>"D014570", "term"=>"Urologic Diseases"}, {"id"=>"D052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D014545", "term"=>"Urinary Calculi"}, {"id"=>"D052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M10693", "name"=>"Kidney Calculi", "asFound"=>"Kidney Stone", "relevance"=>"HIGH"}, {"id"=>"M27126", "name"=>"Nephrolithiasis", "relevance"=>"LOW"}, {"id"=>"M27103", "name"=>"Urolithiasis", "asFound"=>"Urolithiasis", "relevance"=>"HIGH"}, {"id"=>"M5399", "name"=>"Calculi", "relevance"=>"LOW"}, {"id"=>"M17295", "name"=>"Urinary Calculi", "relevance"=>"LOW"}, {"id"=>"M22519", "name"=>"Pathological Conditions, Anatomical", "relevance"=>"LOW"}, {"id"=>"M10698", "name"=>"Kidney Diseases", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-05", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-11", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-27", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-11", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Stone Clearance", "timeFrame"=>"Day 1 and Day 30", "description"=>"The stone clearance at Post-Op Day 1 (POD1) and Post-Op Day 30 (POD30) on non-contrast CT (NCCT)"}]}, "oversightModule"=>{"isUsExport"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"conditions"=>["Renal Stones", "Kidney Stone", "Urolithiasis"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of the study is to assess safety and efficacy of a novel steerable ureteral catheter system, the CVAC System for the treatment of urinary stones."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Candidate for ureteroscopy with laser lithotripsy;\n* Be willing and able to return for and respond to all study-related follow up procedures; and,\n* Have been informed of the nature of the study and have agreed to the IRB approved informed consent form (ICF).\n\nExclusion Criteria:\n\n* Significant morbidities;\n* Unable to meet the treatment and follow up protocol requirements; and,\n* Ureteral or kidney abnormalities."}, "identificationModule"=>{"nctId"=>"NCT06615713", "briefTitle"=>"Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) Using the CVAC® System", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Calyxo, Inc."}, "officialTitle"=>"A Prospective Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) Using the CVAC® Set", "orgStudyIdInfo"=>{"id"=>"CP00003"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System", "description"=>"The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).", "interventionNames"=>["Device: Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System"]}], "interventions"=>[{"name"=>"Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System", "type"=>"DEVICE", "description"=>"The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).", "armGroupLabels"=>["Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Nadiad", "country"=>"India", "facility"=>"Muljibhai Patel Urological Hospital", "geoPoint"=>{"lat"=>22.69385, "lon"=>72.86157}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Calyxo, Inc.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
