Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT06824402

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

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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

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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