Actively Recruiting
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
Led by Mayo Clinic · Updated on 2026-05-01
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating which biopsy collection method, a 1.1 mm cryoprobe or biopsy forceps, better helps diagnose rejection and other important tissue findings in lung transplant recipients. This randomized clinical trial aims to compare the quality and diagnostic value of lung tissue samples obtained by these two methods to improve detection of transplant rejection. Participants will be randomly assigned to receive lung tissue samples either by the cryoprobe, which uses rapid freezing to remove small tissue fragments, or by biopsy forceps, the current standard method that may cause more tissue damage. The cryoprobe collects three biopsies from two different lung lobes, and forceps collect 10-12 biopsies using a disposable device. The study compares sample quality, the amount of tissue collected, and the time required for each method. Participants will undergo biopsy during their scheduled bronchoscopy for lung transplant surveillance and be monitored for any adverse events for up to 30 days after the procedure. Researchers will assess tissue quality, diagnostic yield, sample adequacy, and procedural time to determine which biopsy method provides better results for detecting lung transplant rejection. The trial lasts from the time of biopsy through one month of follow-up.
CONDITIONS
Brief 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 18 or older at the time of consent
- Scheduled for bronchoscopy with transbronchial biopsy for post-transplant lung surveillance or clinical indication
- Able and willing to sign informed consent
You will not qualify if you...
- Known bleeding disorders
- Platelet count less than 50,000 per microliter within 14 days before biopsy
- Current use of systemic anticoagulants or antiplatelet drugs that cannot be paused before biopsy (aspirin alone allowed)
- Unable or unwilling to give informed consent or follow study procedures
- Pregnant or nursing women, or women intending to become pregnant
- Women of childbearing potential who refuse pregnancy testing before enrollment
- Single lung transplant recipients
- International Normalized Ratio (INR) greater than 1.5
- Do Not Resuscitate (DNR) status
- Do Not Intubate (DNI) status
- Investigator judgment that study is not in participant's best interest or suitability for study is poor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo bronchoscopy with transbronchial biopsy using either a miniature cryoprobe or standard biopsy forceps to obtain lung tissue samples for graft surveillance.
1 procedure visit (in-person)
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
J
John Joerns, MD
J
Jackie Reiter
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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