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NCT Number: NCT06824402

Cryoprobe Biopsy and Chronic 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.

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Key information

Conditions

Lung Transplant Rejection

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

John Joerns

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Forceps Biopsy

Device

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

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

Primary outcomes

  1. Quality and diagnostic yield of tissue samples

    Time frame: Baseline

    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.

Secondary outcomes

  1. Time duration

    Time frame: Baseline

    Duration of each individual biopsy procedure from insertion of the bronchoscope after airway has been secured until bronchoscope is withdrawn. .

  2. Tissue sample adequacy

    Time frame: Baseline

    Number of biopsy samples that are adequate to determine rejection based on the presence of well expanded alveoli, as determined by the pathologist.

Study contacts

Contact information is provided by the study sponsor or research team.

Jackie Reiter

CONTACT

[email protected]

507-538-2224

John Joerns, MD

CONTACT

[email protected]

507-284-6616

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 13, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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