Nctid:
NCT06614491
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>600}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-07", "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"=>"2025-07", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Ostomy dataset demographics", "timeFrame"=>"Baseline, single time point", "description"=>"Demographic information"}, {"measure"=>"Ostomy dataset care", "timeFrame"=>"Baseline, single time point", "description"=>"Ostomy care information"}, {"measure"=>"Ostomy dataset images", "timeFrame"=>"Baseline, single time point", "description"=>"Ostomy photos"}], "secondaryOutcomes"=>[{"measure"=>"Real-world image assessment usage by Healthcare professionals (HCPs)", "timeFrame"=>"Baseline, single time point", "description"=>"Assessment via in-person skin assessment by an ostomy care nurse and assessment via examining the skin via photo by a study nurse coordinator"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Ileostomy", "Colostomy", "Urostomy"]}, "descriptionModule"=>{"briefSummary"=>"Study to create an ostomy dataset and collect stoma photos to evaluate images digitally versus in-person ostomy skin assessment.", "detailedDescription"=>"The purpose of this study is to create an ostomy dataset and collect stoma photos to enable evaluation of images digitally versus an in-person ostomy skin assessment. This resultant dataset will be used to evaluate the real-world use of the assessment tool and potentially to facilitate the development of an improved tool for assessing peristomal skin conditions in ostomates."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"600 adult subjects with an ileostomy, colostomy, or urostomy and eligible for study participation according to the inclusion and exclusion criteria.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with ileostomy, colostomy or urostomy\n* Age ≥ 18 years of age\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n- Enterocutaneous fistulae"}, "identificationModule"=>{"nctId"=>"NCT06614491", "briefTitle"=>"SCOPE - Study of Classification for Observational Peristomal Evaluation", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"ConvaTec Inc."}, "officialTitle"=>"A Prospective, Observational Study for the Classification of Peristomal Skin Breakdown", "orgStudyIdInfo"=>{"id"=>"OC-24-448"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Normal skin", "description"=>"Subjects with healthy peristomal skin"}, {"label"=>"L1 complications", "description"=>"Subjects with L1 peristomal complications"}, {"label"=>"L2, L3, L4, L5 & LX complications", "description"=>"Subjects with L2, L3, L4, L5 \\& LX peristomal complications"}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"São Paulo", "country"=>"Brazil", "facility"=>"Convatec Brazil Clinic", "geoPoint"=>{"lat"=>-23.5475, "lon"=>-46.63611}}, {"city"=>"Bogotá", "country"=>"Colombia", "facility"=>"Convatec Colombia Clinic", "geoPoint"=>{"lat"=>4.60971, "lon"=>-74.08175}}, {"city"=>"Medellín", "country"=>"Colombia", "facility"=>"Convatec Colombia Clinic", "geoPoint"=>{"lat"=>6.25184, "lon"=>-75.56359}}], "centralContacts"=>[{"name"=>"Jan Ljungqvist", "role"=>"CONTACT", "email"=>"jan.ljungqvist@convatec.com", "phone"=>"078-255-7961"}, {"name"=>"Janet Kandrevas, MD", "role"=>"CONTACT", "email"=>"janet.kandrevas@convatec.com"}], "overallOfficials"=>[{"name"=>"Sandra Guerrero, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Principal Investigator Colombia"}, {"name"=>"Maria Angela Boccara de Paula, BSN", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Principal Investigator Brazil"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"ConvaTec Inc.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
