Nctid:
NCT06228131
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITHOUT_DNA", "description"=>"urine sample"}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>241}, "targetDuration"=>"10 Days", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-08-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-01-02", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-19", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-01-02", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To evaluate the detection of hCG in the early pregnancy urine samples by investigational device.", "timeFrame"=>"10day", "description"=>"Percentage Pregnancy Results (%) for early pregnancy urine samples on different days from day -8 to day +1 relative to the expected period.\n\nPercentage Pregnancy Results (%): 79% (day -5 relative to the expected period)"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Early Pregnancy"]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the detection of hCG in the early pregnancy urine samples by Human chorionic gonadotropin (HCG) test system."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT"], "maximumAge"=>"55 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"There were 241 subjects who planned to conceive but did not conceive participating in the clinical trial. Of these, 73 women successfully conceived and provided a full cycle of urine samples(10 days, from day -8 to day +1 relative to the expected period) .", "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Female；\n* 18-55 years of age；\n* In a state of preparing for pregnancy;\n* Voluntary and sign informed consent form.\n\nExclusion Criteria:\n\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."}, "identificationModule"=>{"nctId"=>"NCT06228131", "briefTitle"=>"Detection of hCG in Early Pregnancy Clinical Samples", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Andon Health Co., Ltd"}, "officialTitle"=>"Detection of hCG in Early Pregnancy Clinical Samples", "orgStudyIdInfo"=>{"id"=>"IHC-3000-LCFA02"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"subjects who provided early pregnancy urine samples"}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Tianjin", "country"=>"China", "facility"=>"First Teaching hospital of Tianjin University of Traditional Chinese Medicine", "geoPoint"=>{"lat"=>39.14222, "lon"=>117.17667}}, {"city"=>"Tianjin", "country"=>"China", "facility"=>"Internet Hospital of Tianjin Medical University General Hospital", "geoPoint"=>{"lat"=>39.14222, "lon"=>117.17667}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Andon Health Co., Ltd", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
