Nctid:
NCT06226909
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010995", "term"=>"Pleural Diseases"}], "ancestors"=>[{"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}], "browseLeaves"=>[{"id"=>"M13885", "name"=>"Pleural Diseases", "asFound"=>"Pleural Diseases", "relevance"=>"HIGH"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"DIAGNOSTIC", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>234}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2027-08-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-30", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-08-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The diagnostic yield of the two groups", "timeFrame"=>"6 months", "description"=>"the pathology of pleural biopsies will be interpreted by cytopathologists"}], "secondaryOutcomes"=>[{"measure"=>"Procedure time", "timeFrame"=>"1 day", "description"=>"Procedure time"}, {"measure"=>"the rate of pneumothorax & hemothorax", "timeFrame"=>"1 day", "description"=>"Safety"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Pleural Diseases"]}, "descriptionModule"=>{"briefSummary"=>"To investigate the information from shear-wave elastography on pleural tissues will improve the diagnosis of pleural diseases, as to increase the diagnostic yield in ultrasound-guided transthoracic pleura biopsy."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with radiographic evidence of pleural disease\n\nExclusion Criteria:\n\n* Age \\< 18 y/o\n* Patients who cannot hold their breath for 5 seconds"}, "identificationModule"=>{"nctId"=>"NCT06226909", "briefTitle"=>"The Efficacy of Shear-wave Elastography-guided Biopsy for Diagnosis in Pleural Disease", "organization"=>{"class"=>"OTHER", "fullName"=>"National Taiwan University Hospital"}, "officialTitle"=>"The Efficacy of Shear-wave Elastography-guided Biopsy for Diagnosis in Pleural Disease: a Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"202311139RINC"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Shear-wave elastography-guided", "description"=>"based on the shear-wave elastography, the area with the highest elasticity value will be the target area to perform pleural biopsy for at least 6 times", "interventionNames"=>["Procedure: different types of ultrasound technique"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"B-mode ultrasound-guided", "description"=>"based on the B-mode transthoracic ultrasound, the area with the maximal thickness will be the target area to perform pleural biopsy for at least 6 times", "interventionNames"=>["Procedure: different types of ultrasound technique"]}], "interventions"=>[{"name"=>"different types of ultrasound technique", "type"=>"PROCEDURE", "description"=>"Shear-wave elastography-guided or B-mode ultrasound-guided", "armGroupLabels"=>["B-mode ultrasound-guided", "Shear-wave elastography-guided"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"100", "city"=>"Taipei City", "status"=>"RECRUITING", "country"=>"Taiwan", "contacts"=>[{"name"=>"Yao-Wen Kuo", "role"=>"CONTACT", "email"=>"kyw@ntu.edu.tw"}], "facility"=>"National Taiwan University Hospital", "geoPoint"=>{"lat"=>25.04776, "lon"=>121.53185}}], "centralContacts"=>[{"name"=>"Yao-Wen Kuo", "role"=>"CONTACT", "email"=>"kyw@ntu.edu.tw", "phone"=>"0972651821"}], "overallOfficials"=>[{"name"=>"Yao-Wen Kuo", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Taiwan University Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Taiwan University Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
