Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients

NCT06824402 | Recruiting FDA Device

• 1 other identifier: 23-011339
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Transplant Rejection

Keywords

Lung Transplant; Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time duration

  Baseline

• Tissue sample adequacy

  Baseline

Study Arms (2)

Cryoprobe Biopsy Method

EXPERIMENTAL

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

Forceps Biopsy Method

ACTIVE COMPARATOR

Olympus disposable EndoJaw is used to obtain samples as per the standard of clinical care usually resulting in crush artifact.

Device: Forceps Biopsy

Interventions

Forceps Biopsy DEVICE

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

Forceps Biopsy Method

Cryoprobe Biopsy DEVICE

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

Cryoprobe Biopsy Method

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Study Officials

• John Joerns

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Joerns, MD

CONTACT

507-284-6616; joerns.john@mayo.edu

Jackie Reiter

CONTACT

507-538-2224; reiter.jacqulyn@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Allocation will not be known to either the patient or bronchoscopist until the intra-procedural randomization timepoint, after which blinding of the bronchoscopist is not possible due to the nature of the procedure.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)