NCT06824402 Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients
| NCT ID | NCT06824402 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Lung Transplant Rejection |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-02-17 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-02-17 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
John Joerns
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06824402 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Lung Transplant Rejection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06824402 currently recruiting?
Yes, NCT06824402 is actively recruiting participants. Contact the research team at joerns.john@mayo.edu for enrollment information.
Where is the NCT06824402 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06824402 clinical trial?
NCT06824402 is sponsored by Mayo Clinic. The principal investigator is John Joerns at Mayo Clinic. The trial plans to enroll 100 participants.