NCT06824402 · Mayo Clinic
Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients
What this study is about
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: Does the 1.
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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: Does the 1.1 mm cryoprobe or the biopsy forceps provide better quality samples of lung tissue for detecting rejection in transplant recipients? How much tissue is adequate for lung transplant 1.1 mm cryobiopsy samples as compared to biopsy forceps? Which samples received by the pathologist did they find they were most confident to exclude rejection, based on their satisfaction with the samples? Which collection method has the least amount of procedural time? Researchers will compare lung tissue samples obtained using a 1.1mm cryoprobe and a biopsy forceps during the lung transplant. Participants will: Be randomly assigned to receive either the cryoprobe or biopsy forceps collection method at the time of biopsy. Assessed for any adverse events following the biopsy for up to 30 days after transplant.
Interventions
DEVICE
Forceps Biopsy
10-12 transbronchial lung biopsies will be obtained using standard of care biopsy forceps: Olympus disposable EndoJaw (FB-211), Olympus, USA
DEVICE
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
Primary outcome measures
Quality and diagnostic yield of tissue samples
Time frame: Baseline
Histological accessibility grade is determined by the pathologist according to the Lung Allograft Standard Histological Analysis (LASHA) scale and the 2007 Revision of the 1996 working formulation for the Standardization of Nomenclature in the Diagnosis of Lung Rejection, published by the ISHLT.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and female lung transplant recipients age \>18 at the time of informed consent
- Patients clinically meet indication for post-transplant lung biopsy or planned routine surveillance and have been scheduled for bronchoscopy with transbronchial biopsy.
- Be willing and able to sign the informed consent.
Exclusion criteria
- Patients with known bleeding diathesis
- Platelet count \<50,000 per μL within 14 days of the biopsy procedure
- 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)
- Inability or unwillingness to give informed consent or study procedures
- Pregnant or nursing females, or females who intend to become pregnant
- Females of child-bearing potential who decline a pregnancy test prior to enrollment
- 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.
- International Normalized Ratio (INR) \>1.5
- Do Not Resuscitate (DNR) status
- Do Not Intubate (DNI) status
- Single lung transplant recipients
Where
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations