[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620019":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":22,"studyPopulation":22,"armGroups":31,"interventions":52,"overallOfficials":22,"centralContacts":22,"locations":61,"responsibleParty":75,"collaborators":22,"id":79,"slug":22,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":22,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":22,"enrollmentInfo":87,"targetDuration":22,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":22,"overallStatus":97,"whyStopped":22,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Guangzhou Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of adverse events","The Incidence of adverse events = (the number of adverse event \u002F the number of procedures) \\* 100%","7 days after procedure",[14,18],{"measure":15,"description":16,"timeFrame":17},"Diagnostic yield","The diagnostic yield = (the number of successful diagnoses \u002F the number of completed biopsies) \\* 100%","Immediately after the procedure",{"measure":19,"description":20,"timeFrame":21},"Hole-in-lesion rate","The rate of \"hole-in-lesion\" = (The number of cases with \"hole-in-lesion\" \u002F The total number of cases that completed biopsy) \\* 100% The definition of \"Hole-in-lesion\": After cryobiopsy, a CBCT scan is performed, and the CBCT image shows the presence of a cavity within the lesion.","During the procedure",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","PARALLEL","DIAGNOSTIC",{"masking":28,"maskingDescription":22,"whoMasked":29},"SINGLE",[30],"PARTICIPANT",[32,38,44,48],{"label":33,"type":34,"description":35,"interventionNames":36},"Diffuse- Conventional Group","ACTIVE_COMPARATOR","The Diffuse-Conventional Group used conventional cryobiopsy for lung lesions.",[37],"Other: Conventional cryobiopsy",{"label":39,"type":40,"description":41,"interventionNames":42},"Diffuse- Combined Group","EXPERIMENTAL","The Diffuse-Combined Group used CLE combined with cryobiopsy for lung lesions",[43],"Other: Confocal laser endomicroscopy combined cryobiopsy",{"label":45,"type":34,"description":46,"interventionNames":47},"Localized - Convention Group","The Localized-Conventional Group used conventional cryobiopsy for lung lesions.",[37],{"label":49,"type":40,"description":50,"interventionNames":51},"Localized - Combined Group","The Localized-Combined Group used CLE combined with cryobiopsy for lung lesions",[43],[53,57],{"type":6,"name":54,"description":55,"armGroupLabels":56,"otherNames":22},"Confocal laser endomicroscopy combined cryobiopsy","Patients in the combined group will undergo CLT combined with cryobiopsy for lung lesions.",[39,49],{"type":6,"name":58,"description":59,"armGroupLabels":60,"otherNames":22},"Conventional cryobiopsy","Patients in the conventional group will underg cryobiopsy for lung lesions.",[33,45],[62],{"facility":63,"status":22,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":22},"The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163","Guangzhou","Guangdong","510100","China","CN",{"type":70,"coordinates":71},"Point",[72,73],113.25,23.11667,{"lat":73,"lon":72},{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Li Shiyue","professor","100620019",false,"NCT07352176","Study on the Effectiveness and Safety of CLE Combined With Cryobiopsy for Diagnosis of Pulmonary Lesions","Study on the Effectiveness and Safety of Confocal Laser Endomicroscopy Combined With Ultrafine Cryoprobe for Biopsy Diagnosis of Pulmonary Lesions","Inclusion Criteria:\n\n1. Patients over 18 years old with lung lesions indicated by chest CT;\n2. Preoperative CT indicates that the lung lesion to be biopsied has a bronchus leading to it;\n3. Able to understand and voluntarily sign the written informed consent form. -\n\nExclusion Criteria:\n\n1. Patients with contraindications to anesthesia or bronchoscopy;\n2. Patients with uncorrectable coagulation disorders;\n3. Patients who cannot discontinue therapeutic anticoagulants within an appropriate time interval before surgery;\n4. Patients with severe liver or kidney dysfunction, mental illness, etc.;\n5. Pregnant or lactating patients;\n6. Patients without a clear histological or clinical diagnosis;\n7. Subjects deemed unsuitable for participation in this study by the investigator.","ALL","18 Years",{"count":88,"type":89},40,"ESTIMATED","INTERVENTIONAL",[92],"NA","Forty subjects meeting the inclusion and exclusion criteria were recruited at a single center and signed informed consent forms. Among them, 20 patients in the diffuse group and 20 patients in the localized group were randomly assigned to the conventional radial endobronchial ultrasound combined with cryobiopsy group (conventional group) and the confocal laser endomicroscopy combined with cryobiopsy group (combined group). During the operation, the operator manipulated the bronchoscope to reach the lesion. After confirming the arrival at the lesion using radial endobronchial ultrasound\u002Fconfocal laser endomicroscopy, cryobiopsy was performed, and the size of the sample was recorded. CBCT scanning was conducted after cryobiopsy. If there was no hole-in-lesion image, cryobiopsy was performed again under CBCT guidance. CBCT scanning was performed after biopsy to determine whether there were any adverse events.",[95,96],"Pulmonary Lesion","Lung Cancer","NOT_YET_RECRUITING","2026-01-11",{"date":100,"type":101},"2026-01-20","ACTUAL",{"date":103,"type":89},"2026-02-01",{"date":105,"type":89},"2026-12-31",{"name":5,"class":6},1]