Cryoprobe Biopsy in Chronic Rejection in Lung Transplant Recipients

Overview

About this study

The purpose of this study is to to compare the histological quality and diagnostic yield of tissue samples acquired using a 1.1 mm cryoprobe with those obtained through forceps biopsies in lung transplant recipients for graft surveillance.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/04/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Joerns, M.D.

Open for enrollment

Contact information:

Gabriel Ortiz Jaimes M.D.

OrtizJaimes.Gabriel@mayo.edu

More information

Publications

Publications are currently not available