Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06824402

Conditions

Lung Transplant Rejection

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Forceps Biopsy

Cryoprobe Biopsy

Study Details

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

Study ID

NCT06824402

Start date

Feb 17, 2025

Status verified date

Apr, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Forceps Biopsy

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

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

Primary outcome measure

  • Quality and diagnostic yield of tissue samples [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

John Joerns, MD

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

Jackie Reiter

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

John Joerns

More Information

Sponsor

Mayo Clinic

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Lung Transplant
  • Bronchoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-05-01.