Nctid:
NCT06614491
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>600}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-11", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-11", "completionDateStruct"=>{"date"=>"2026-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-11-04", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-11-07", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-11", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Reliability of SACS assessment", "timeFrame"=>"Baseline", "description"=>"The equivalence of weighted Kappa concordance between SACS assessment via in-person skin assessment by an ostomy care nurse and SACS assessment via examining the skin via photo by a study nurse coordinator"}], "secondaryOutcomes"=>[{"measure"=>"Ostomy dataset", "timeFrame"=>"Baseline", "description"=>"Frequency of peristomal skin health classification scores in 600 consecutive ostomates"}]}, "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 enable evaluation of images digitally versus an in-person ostomy skin assessment.", "detailedDescription"=>"The purpose of this study is to create an ostomy dataset and collect stoma photos to enable SACS 2.0 evaluation of images digitally versus an in-person ostomy skin assessment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"A total of 600 Subjects, or 200 Subjects with ileostomy, colostomy, or urostomy peristomal skin categories", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with ileostomy, colostomy or urostomy\n* Age ≥ 18 years of age\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Enterocutaneous fistulae\n* Patients with two or more ostomies"}, "identificationModule"=>{"nctId"=>"NCT06614491", "briefTitle"=>"SCOPE - Single-Point Classification Observational Peristomal Evaluation", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"ConvaTec Inc."}, "officialTitle"=>"A Single-Time-Point, Observational Study to Evaluate Interrater Reliability of SACS 2.0 for the Assessment of Peristomal Skin Health in Ostomates", "orgStudyIdInfo"=>{"id"=>"OC-24-448"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Ileostomy", "description"=>"Subjects with ileostomy"}, {"label"=>"Colostomy", "description"=>"Subjects with colostomy"}, {"label"=>"Urostomy", "description"=>"Subjects with urostomy"}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"São Paulo", "country"=>"Brazil", "facility"=>"ConvaCare clinic", "geoPoint"=>{"lat"=>-23.5475, "lon"=>-46.63611}}, {"city"=>"Bogotá", "country"=>"Colombia", "facility"=>"ConvaCare clinic", "geoPoint"=>{"lat"=>4.60971, "lon"=>-74.08175}}, {"city"=>"Medellín", "country"=>"Colombia", "facility"=>"ConvaCare clinic", "geoPoint"=>{"lat"=>6.25184, "lon"=>-75.56359}}], "centralContacts"=>[{"name"=>"Luisa Grass Blanco, MD", "role"=>"CONTACT", "email"=>"luisa.grass@convatec.com", "phone"=>"57-3183228360"}, {"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, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Principal Investigator Brazil"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"ConvaTec Inc.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
