Nctid:
NCT06228118
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M9168", "name"=>"Chorionic Gonadotropin", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>502}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-08-04", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-09-02", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-28", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-09-02", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Comparison results", "timeFrame"=>"30minute", "description"=>"Compare the test results conducted by professionals using investigational device and the comparator, and the positive percent agreement (PPA=100%), negative percent agreement (NPA=100%) and overall percent agreement (OPA=100%) were calculated."}], "secondaryOutcomes"=>[{"measure"=>"Evaluate the usability and user comprehension of investigational device", "timeFrame"=>"30minute", "description"=>"The accuracy rate of the critical task is 100%. The Overall Percent Agreement for investigational device is 100% when conducted by a lay user. The accuracy rate of the each questions in the Knowledge assessment is 100%, and 100% of the Ease of operation assessment chose normal, easy, or very easy."}]}, "oversightModule"=>{"isUsExport"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Early Pregnancy"]}, "descriptionModule"=>{"briefSummary"=>"This clinical trial consisted of lay user study and method comparison study. Method comparison study: evaluate the clinical performance by comparing the results of new device and FDA cleared device (the comparator) tested on the same sample by professionals.\n\nLay user study: evaluate the usability of by comparing the results of new device on the same sample tested by professionals and lay user, and by lay users complete the questionnaire."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT"], "maximumAge"=>"55 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"A total of 502 subjects with ages from 18-55 years old were enrolled . Among the 502 total subjects, 369 subjects aged between 18 and 55 years old voluntarily participated in the Lay User Study.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Method comparison study exclusion criteria\n\n * Female；\n * 18-55 years of age；\n * Voluntary and sign informed consent form.\n2. Lay user study inclusion criteria\n\n * Female；\n * 18-55 years of age；\n * Voluntary and sign informed consent form；\n * Willingness to perform self-test of investigational device；\n * Have the ability to read English.\n\nExclusion Criteria:\n\n1. Method comparison study exclusion criteria\n\n * Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；\n * Within 8 weeks of childbirth or abortion；\n * The investigator has reason to believe that it is inappropriate for subjects to participate in the study.\n2. Lay user study inclusion criteria\n\n * Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；\n * Within 8 weeks of childbirth or abortion；\n * The investigator has reason to believe that it is inappropriate for subjects to participate in the study；\n * Background in a medical or laboratory testing."}, "identificationModule"=>{"nctId"=>"NCT06228118", "briefTitle"=>"Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Andon Health Co., Ltd"}, "officialTitle"=>"Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System", "orgStudyIdInfo"=>{"id"=>"IHC-3000-LCFA01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Subjects enrolled in method comparison study only"}, {"label"=>"Subjects enrolled in both the method comparison study and lay user study"}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Tianjin", "country"=>"China", "facility"=>"First Teaching hospital of Tianjin University of Traditional Chinese Medicine", "geoPoint"=>{"lat"=>39.14222, "lon"=>117.17667}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Andon Health Co., Ltd", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
