Nctid:
NCT06229275
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D002583", "term"=>"Uterine Cervical Neoplasms"}], "ancestors"=>[{"id"=>"D014594", "term"=>"Uterine Neoplasms"}, {"id"=>"D005833", "term"=>"Genital Neoplasms, Female"}, {"id"=>"D014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D002577", "term"=>"Uterine Cervical Diseases"}, {"id"=>"D014591", "term"=>"Uterine Diseases"}, {"id"=>"D005831", "term"=>"Genital Diseases, Female"}, {"id"=>"D052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}], "browseLeaves"=>[{"id"=>"M5830", "name"=>"Uterine Cervical Neoplasms", "asFound"=>"Cervical Cancer", "relevance"=>"HIGH"}, {"id"=>"M5826", "name"=>"Uterine Cervical Dysplasia", "relevance"=>"LOW"}, {"id"=>"M17342", "name"=>"Uterine Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8945", "name"=>"Genital Neoplasms, Female", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M5825", "name"=>"Uterine Cervical Diseases", "relevance"=>"LOW"}, {"id"=>"M17339", "name"=>"Uterine Diseases", "relevance"=>"LOW"}, {"id"=>"M8943", "name"=>"Genital Diseases, Female", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital 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"=>"T4202", "name"=>"Oculocerebral Syndrome With Hypopigmentation", "relevance"=>"LOW"}, {"id"=>"T1074", "name"=>"Cervical Intraepithelial Neoplasia", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SCREENING", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>200}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-02", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-03-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-19", "studyFirstSubmitDate"=>"2024-01-10", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Comparison of the samples for the Predicate Device versus PPS device", "timeFrame"=>"Baseline", "description"=>"Data of Adequate versus Inadequate will be reported to include a positive percent agreement (PPA) defined as PPA= A/(A+C) and the negative percent agreement (NPA) defined as NPA = D/(B+D) along with their 95% confidence bounds using the Clopper-Pearson method."}], "secondaryOutcomes"=>[{"measure"=>"The Comparison of Cell Types of the PPS Device versus the Predicate Device", "timeFrame"=>"Baseline", "description"=>"The PPS Device and the Predicate Device cell types will be measured against the 2014 Besthesda cytology categories that will be displayed in a 8 x 8 contingency table."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["pap smear collection"], "conditions"=>["Cervical Cancer Screening"]}, "descriptionModule"=>{"briefSummary"=>"This purpose of this research study is to determine the effectiveness of the Personal Pap Smear TM Device to collect adequate cervical cell samples for cytology examination when compared with the Rover Cervex-Brush (Cervix-Examination Brush).", "detailedDescription"=>"To determine the effectiveness of the Personal Pap Smear TM Device to collect adequate (as defined by Bethesda Guidelines 2014) cervical cell samples for cytology examination as compared with the Rover Cervex-Brush (Cervix-Examination Brush)."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"21 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adult women, aged 21-65 years old.\n* Do not have any medical or psychiatric condition affecting the ability to give voluntary informed consent.\n* Be able to read and understand English\n\nExclusion Criteria:\n\n* Participants currently on menses\n* Inability to provide Informed Consent\n* Previous total hysterectomy\n* History of radiation treatment for cervical cancer\n* Pregnancy\n* Medical condition that interferes with conduct of study, in investigator's opinion\n* Evidence of active cervical infection requiring treatment\n* Known bleeding diathesis"}, "identificationModule"=>{"nctId"=>"NCT06229275", "briefTitle"=>"Study to Evaluate the Effectiveness of the Personal Pap Smear Device™ for Collection of Cervical Cells", "organization"=>{"class"=>"OTHER", "fullName"=>"Morehouse School of Medicine"}, "officialTitle"=>"A Phase III Cross-Over Comparative Study to Evaluate the Effectiveness of the Rover Cervex-Brush Device vs. the Personal Pap Smear Device™ for Collection of Cervical Cells for Detecting Cervical Dysplasia or Neoplasia", "orgStudyIdInfo"=>{"id"=>"2011440"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Pap smear collection using the Personal Pap Smear (PPS) Device", "interventionNames"=>["Device: Pap smear collection using the Personal Pap Smear (PPS) Device"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Pap smear collection using the Rovers Cervex-Brush", "interventionNames"=>["Device: Active Comparator: Pap smear collection using the Rovers Cervex-Brush"]}], "interventions"=>[{"name"=>"Pap smear collection using the Personal Pap Smear (PPS) Device", "type"=>"DEVICE", "description"=>"Diagnostic Test: Use of PPS device to collect cervical cells during pap smear collection.", "armGroupLabels"=>["Pap smear collection using the Personal Pap Smear (PPS) Device"]}, {"name"=>"Active Comparator: Pap smear collection using the Rovers Cervex-Brush", "type"=>"DEVICE", "description"=>"Diagnostic Test: Use of Rovers Cervex-Brush to collect cervical cells during pap smear collection.", "armGroupLabels"=>["Pap smear collection using the Rovers Cervex-Brush"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Regina K Leonis, MD", "role"=>"CONTACT", "email"=>"rleonis@msm.edu", "phone"=>"4047565713"}, {"name"=>"Jan Morgan-Billingslea", "role"=>"CONTACT", "email"=>"jmogan@msm.edu", "phone"=>"404-756-5713"}], "overallOfficials"=>[{"name"=>"Regina K Leonis, MD, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Morehouse School of Medicine"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Morehouse School of Medicine", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"GyneConcepts, Inc.", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Assistant Professor", "investigatorFullName"=>"Regina Leonis", "investigatorAffiliation"=>"Morehouse School of Medicine"}}}}
