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

A Study to Evaluate the Feasibility of Robotic Bronchoscopy-guided Miniature Cryoprobe Biopsy of Peripheral Pulmonary Lesions

This research is being done to evaluate the feasibility, and biopsy quality, of using a 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue.

Study Overview

• Status: Completed
• Conditions: Lung Diseases, Obstructive; Bronchi--Diseases; Lesions Mass
• Intervention / Treatment: Device: Cryoprobe biopsy; Procedure: Forceps biopsy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karlyn Pierson, MAN, RN; Phone Number: (507) 293-0807; Email: pierson.karlyn@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard forceps biopsy then research cryoprobe biopsy; Subjects scheduled for a biopsy of lung lesions using robotic bronchoscopy as part of their standard of care will have the lung lesion biopsied using forceps first followed by cryoprobe.	Device: Cryoprobe biopsy; A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue; Procedure: Forceps biopsy; Biopsy forceps used to collect tissue
Experimental: Research cryoprobe biopsy then standard forceps biopsy; Subjects scheduled for a biopsy of lung lesions using robotic bronchoscopy as part of their standard of care will have the lung lesion biopsied using the cryoprobe first followed by forceps.	Device: Cryoprobe biopsy; A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue; Procedure: Forceps biopsy; Biopsy forceps used to collect tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to successfully obtain sample	Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of biopsy procedure	Total time of biopsy procedure from first insertion of probe into robotic sheath to removal of specimen.	Biopsy procedure, approximately 3 hours
Freezing time for cryoprobe biopsies	Total freezing time for cryoprobe biopsies, measured in seconds	Biopsy procedure, approximately 60 seconds
Number of successful biopsy attempts	One attempt is defined as insertion of the biopsy probe into the robotic sheath, activation/employment of the biopsy mechanism at the target site and retrieval via the robotic sheath. A biopsy attempt is successful if a tissue sample that is considered by the bronchoscopist to be adequate for further pathological analysis can be retrieved.	Biopsy procedure, approximately 3 hours
Histological accessibility grade	Pathologic description ranging from insufficient to diagnostic material	Pathology review, approximately 1 day
Histological diagnostic yield	Defined as the ability of the pathologist to make a diagnostic statement based on the histological analysis of the obtained tissue samples. Graded 1-4 with 1 being insufficent tissue and 4 being diagnostic material.	Pathology review, approximately 1 day
Total histological area (mm^2)		Pathology review, approximately 1 day
Crush artifacts (percent total area)		Pathology review, approximately 1 day
Other pathologic artifacts present in the tissue that obscure pathological assessment (percent total area)		Pathology review, approximately 1 day
Different tissue types in the tissue specimen	alveoli, bronchus, mucus, blood, target tissue; % total area	Pathology review, approximately 1 day

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Erbe USA Incorporated
• Investigators: Principal Investigator: Ryan Kern, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): July 11, 2023
• Study Completion (Actual): July 11, 2023

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive
• Other Study ID Numbers: 21-008716

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes