Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients

Launched by MAYO CLINIC · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for taking lung tissue samples from patients who have received a lung transplant. The goal is to find out which method—using a 1.1 mm cryoprobe or biopsy forceps—provides better quality samples for detecting lung transplant rejection. Researchers want to know which method gives the most reliable samples for doctors to assess, how much tissue is considered enough, and which method takes less time to perform.

To participate in this trial, you need to be over 18 years old and a lung transplant recipient who is scheduled for a routine check-up called a bronchoscopy. You should also be able to sign an informed consent form. If you join the study, you will randomly be assigned to receive one of the two sampling methods. After the procedure, your health will be monitored for up to 30 days to check for any side effects. This trial is currently recruiting participants, and it’s important to know that certain health conditions may exclude you from participating.

Gender

ALL

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