Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe

Overview

About this study

The purpose of this randomized control study is to evaluate the feasibility of using a miniature (1.1 mm) cryoprobe to perform biopsy of peripheral pulmonary lesions using robotic bronchoscopy.

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 patient’s age ≥ 18 at the time of informed consent.
  • Patient clinically meets indication for peripheral lung nodule biopsy and has been scheduled for robotic bronchoscopy.

Lesion Criteria:

  • Pulmonary nodules of 8-50mm in largest dimension.

Exclusion Criteria:

  • Patients with known bleeding diathesis; Platelet count < 50,000.
  • 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.
  • Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment.
  • Pulmonary hypertension, defined as a right ventricular systolic pressure > 50 mmHg.
  • Individuals with current or recent systematic conditions, such as, acute kidney injury, or conditions that would mandate anticoagulation, such as a recent coronary stent.
  • International Normalized Ratio (INR) < 1.5.
  • Do Not Resuscitate (DNR) status; Do Not Intubate (DNI) status.

Eligibility last updated 10/20/21. 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

Ryan Kern, M.D.

Closed for enrollment

Contact information:

Thoracic Surgery Research Unit

(877) 526-9172

More information

Publications

Publications are currently not available