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

Primary Purpose

Bronchi--Diseases, Lung Diseases, Obstructive, Lesions Mass

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryoprobe biopsy
Forceps biopsy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bronchi--Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard forceps biopsy then research cryoprobe biopsy

Research cryoprobe biopsy then standard forceps biopsy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Ability to successfully obtain sample
Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis

Secondary Outcome Measures

Duration of biopsy procedure
Total time of biopsy procedure from first insertion of probe into robotic sheath to removal of specimen.
Freezing time for cryoprobe biopsies
Total freezing time for cryoprobe biopsies, measured in 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.
Histological accessibility grade
Pathologic description ranging from insufficient to diagnostic material
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.
Total histological area (mm^2)
Crush artifacts (percent total area)
Other pathologic artifacts present in the tissue that obscure pathological assessment (percent total area)
Different tissue types in the tissue specimen
alveoli, bronchus, mucus, blood, target tissue; % total area

Full Information

First Posted
May 20, 2022
Last Updated
September 25, 2023
Sponsor
Mayo Clinic
Collaborators
Erbe USA Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT05399082
Brief Title
Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe
Official Title
A Study to Evaluate the Feasibility of Robotic Bronchoscopy-guided Miniature Cryoprobe Biopsy of Peripheral Pulmonary Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
July 11, 2023 (Actual)
Study Completion Date
July 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Erbe USA Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchi--Diseases, Lung Diseases, Obstructive, Lesions Mass

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard forceps biopsy then research cryoprobe biopsy
Arm Type
Experimental
Arm Description
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.
Arm Title
Research cryoprobe biopsy then standard forceps biopsy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cryoprobe biopsy
Intervention Description
A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue
Intervention Type
Procedure
Intervention Name(s)
Forceps biopsy
Intervention Description
Biopsy forceps used to collect tissue
Primary Outcome Measure Information:
Title
Ability to successfully obtain sample
Description
Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Duration of biopsy procedure
Description
Total time of biopsy procedure from first insertion of probe into robotic sheath to removal of specimen.
Time Frame
Biopsy procedure, approximately 3 hours
Title
Freezing time for cryoprobe biopsies
Description
Total freezing time for cryoprobe biopsies, measured in seconds
Time Frame
Biopsy procedure, approximately 60 seconds
Title
Number of successful biopsy attempts
Description
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.
Time Frame
Biopsy procedure, approximately 3 hours
Title
Histological accessibility grade
Description
Pathologic description ranging from insufficient to diagnostic material
Time Frame
Pathology review, approximately 1 day
Title
Histological diagnostic yield
Description
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.
Time Frame
Pathology review, approximately 1 day
Title
Total histological area (mm^2)
Time Frame
Pathology review, approximately 1 day
Title
Crush artifacts (percent total area)
Time Frame
Pathology review, approximately 1 day
Title
Other pathologic artifacts present in the tissue that obscure pathological assessment (percent total area)
Time Frame
Pathology review, approximately 1 day
Title
Different tissue types in the tissue specimen
Description
alveoli, bronchus, mucus, blood, target tissue; % total area
Time Frame
Pathology review, approximately 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Kern, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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

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