RecruitingNot ApplicableNCT06824402

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


Sponsor

Mayo Clinic

Enrollment

100 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Cryoprobe Biopsy and a medical device called Forceps Biopsy for people with lung transplant rejection. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEForceps Biopsy

10-12 transbronchial lung biopsies will be obtained using standard of care biopsy forceps: Olympus disposable EndoJaw (FB-211), Olympus, USA

DEVICECryoprobe 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


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06824402


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