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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Transplant Rejection
• Intervention / Treatment: Device: Cryoprobe Biopsy; Device: Forceps Biopsy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jackie Reiter; Phone Number: 507-538-2224; Email: reiter.jacqulyn@mayo.edu
• Study Contact Backup: Name: John Joerns, MD; Phone Number: 507-284-6616; Email: joerns.john@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: John Joerns

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Male and female lung transplant recipients age >18 at the time of informed consent
• Patients clinically meet indication for post-transplant lung biopsy or planned routine surveillance and have been scheduled for bronchoscopy with transbronchial biopsy.
• Be willing and able to sign the informed consent.

Exclusion Criteria

• Patients with known bleeding diathesis
• Platelet count <50,000 per μL within 14 days of the biopsy procedure
• Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable)
• Inability or unwillingness to give informed consent or study procedures
• Pregnant or nursing females, or females who intend to become pregnant
• Females of child-bearing potential who decline a pregnancy test prior to enrollment
• If an investigator does not feel that this study is in the subject's best interest or would be a good fit for the study.
• International Normalized Ratio (INR) >1.5
• Do Not Resuscitate (DNR) status
• Do Not Intubate (DNI) status
• Single lung transplant recipients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryoprobe Biopsy Method; 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; 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
Active Comparator: Forceps Biopsy Method; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time duration	Duration of each individual biopsy procedure from insertion of the bronchoscope after airway has been secured until bronchoscope is withdrawn. .	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.	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: John Joerns, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Bronchoscopy; Lung Transplant
• Other Study ID Numbers: 23-011339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No