An interventional study of Forceps Biopsy and Cryoprobe Biopsy in Lung Transplant Rejection, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Health services research
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.
The purpose of this 1:1 randomized clinical trial is to compare the histological quality and diagnostic yield of tissue samples acquired using a 1.1 mm cryoprobe with those obtained with biopsy forceps in lung transplant recipients for graft surveillance.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Cryoprobes which are flexible catheters that can be passed through the channel of a bronchoscope. Rapid cooling of tissue results from the Joule-Thomson effect which causes tissue to freeze and adhere to the probe. The biopsy is obtained by subsequently avulsing small fragments of tissue.
Device: Cryoprobe Biopsy
Olympus disposable EndoJaw is used to obtain samples as per the standard of clinical care usually resulting in crush artifact.
Device: Forceps Biopsy
10-12 transbronchial lung biopsies will be obtained using standard of care biopsy forceps: Olympus disposable EndoJaw (FB-211), Olympus, USA
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
Quality and diagnostic yield of tissue samples
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.
Time frame: Baseline
Time duration
Duration of each individual biopsy procedure from insertion of the bronchoscope after airway has been secured until bronchoscope is withdrawn. .
Time frame: Baseline
Tissue sample adequacy
Number of biopsy samples that are adequate to determine rejection based on the presence of well expanded alveoli, as determined by the pathologist.
Time frame: Baseline
Plan to share: No
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