[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579446":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":62,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cryoprobe Biopsy Method","EXPERIMENTAL","Cryoprobes which are flexible catheters that can be passed through the channel of a bronchoscope. Rapid cooling of tissue results from the Joule-Thomson effect which causes tissue to freeze and adhere to the probe. The biopsy is obtained by subsequently avulsing small fragments of tissue.",[13],"Device: Cryoprobe Biopsy",{"label":15,"type":16,"description":17,"interventionNames":18},"Forceps Biopsy Method","ACTIVE_COMPARATOR","Olympus disposable EndoJaw is used to obtain samples as per the standard of clinical care usually resulting in crush artifact.",[19],"Device: Forceps Biopsy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Forceps Biopsy","10-12 transbronchial lung biopsies will be obtained using standard of care biopsy forceps: Olympus disposable EndoJaw (FB-211), Olympus, USA",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Cryoprobe Biopsy","3 transbronchial lung biopsies of two separate lobes will be obtained using a flexible cryoprobe: single-use, ø 1.1 mm (Erbe Elektromedizin GmbH, 20402-401) used with ERBECRYO 2 (Erbe Elektromedizin GmbH, 10402-000",[9],[32],{"name":33,"affiliation":5,"role":34},"John Joerns","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"John Joerns, MD","CONTACT","507-284-6616","joerns.john@mayo.edu",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Jackie Reiter","507-538-2224","reiter.jacqulyn@mayo.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Mayo Clinic in Rochester","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-92.4699,44.02163,{"lat":58,"lon":57},[61],{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"John O. Joerns","Principal Investigator","100579446","cryoprobe-biopsy-and-chronic-rejection-in-lung-transplant-recipients-100579446",false,"NCT06824402","Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients","A Prospective, Randomized Clinical Trial to Evaluate the Feasibility of Miniature Cryoprobe Biopsy to Detect Acute and Chronic Lung Transplant Rejection in Lung Transplant Recipients","Inclusion Criteria\n\n* Male and female lung transplant recipients age \\>18 at the time of informed consent\n* Patients clinically meet indication for post-transplant lung biopsy or planned routine surveillance and have been scheduled for bronchoscopy with transbronchial biopsy.\n* Be willing and able to sign the informed consent.\n\nExclusion Criteria\n\n* Patients with known bleeding diathesis\n* Platelet count \\<50,000 per μL within 14 days of the biopsy procedure\n* Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable)\n* Inability or unwillingness to give informed consent or study procedures\n* Pregnant or nursing females, or females who intend to become pregnant\n* Females of child-bearing potential who decline a pregnancy test prior to enrollment\n* If an investigator does not feel that this study is in the subject's best interest or would be a good fit for the study.\n* International Normalized Ratio (INR) \\>1.5\n* Do Not Resuscitate (DNR) status\n* Do Not Intubate (DNI) status\n* Single lung transplant recipients","ALL","18 Years","99 Years",{"count":76,"type":77},100,"ESTIMATED","INTERVENTIONAL",[80],"NA","The goal of this clinical trial is to evaluate which biopsy collection method helps to better diagnose rejection and relevant pathologic findings in lung transplant recipients. The main questions it aims to answer are:\n\nDoes the 1.1 mm cryoprobe or the biopsy forceps provide better quality samples of lung tissue for detecting rejection in transplant recipients?\n\nHow much tissue is adequate for lung transplant 1.1 mm cryobiopsy samples as compared to biopsy forceps?\n\nWhich samples received by the pathologist did they find they were most confident to exclude rejection, based on their satisfaction with the samples?\n\nWhich collection method has the least amount of procedural time?\n\nResearchers will compare lung tissue samples obtained using a 1.1mm cryoprobe and a biopsy forceps during the lung transplant.\n\nParticipants will:\n\nBe randomly assigned to receive either the cryoprobe or biopsy forceps collection method at the time of biopsy.\n\nAssessed for any adverse events following the biopsy for up to 30 days after transplant.",[83],"Lung Transplant Rejection",[85,86],"Lung Transplant","Bronchoscopy","2026-04-27",{"date":89,"type":90},"2026-05-01","ACTUAL",{"date":92,"type":90},"2025-02-17",{"date":94,"type":77},"2027-09-30",{"name":5,"class":6},1]