Actively Recruiting
Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients
Led by Mayo Clinic · Updated on 2026-05-01
100
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial 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 1.1 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.
CONDITIONS
Official Title
Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female lung transplant recipients aged over 18 at the time of consent
- Scheduled for post-transplant lung biopsy or routine surveillance bronchoscopy with transbronchial biopsy
- Willing and able to provide informed consent
You will not qualify if you...
- Known bleeding disorders
- Platelet count less than 50,000 per microliter within 14 days before biopsy
- Use of systemic blood thinners or antiplatelet drugs that cannot be stopped before biopsy (aspirin alone is allowed)
- Unable or unwilling to give informed consent or participate in study procedures
- Pregnant or nursing females, or females planning pregnancy
- Females of childbearing potential who refuse pregnancy testing before enrollment
- Investigator judgment that the study is not in the participant's best interest
- International Normalized Ratio (INR) greater than 1.5
- Do Not Resuscitate (DNR) or Do Not Intubate (DNI) status
- Recipients of single lung transplants
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
J
John Joerns, MD
CONTACT
J
Jackie Reiter
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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