Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Ability to successfully obtain sample [Baseline]
Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis
Secondary Outcome Measures
- Duration of biopsy procedure [Biopsy procedure, approximately 3 hours]
Total time of biopsy procedure from first insertion of probe into robotic sheath to removal of specimen.
- Freezing time for cryoprobe biopsies [Biopsy procedure, approximately 60 seconds]
Total freezing time for cryoprobe biopsies, measured in seconds
- Number of successful biopsy attempts [Biopsy procedure, approximately 3 hours]
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 [Pathology review, approximately 1 day]
Pathologic description ranging from insufficient to diagnostic material
- Histological diagnostic yield [Pathology review, approximately 1 day]
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) [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 [Pathology review, approximately 1 day]
alveoli, bronchus, mucus, blood, target tissue; % total area
Eligibility Criteria
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:
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Patients with known bleeding diathesis; Platelet count < 50,000.
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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).
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Inability or unwillingness to give informed consent.
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Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment.
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Pulmonary hypertension, defined as a right ventricular systolic pressure > 50 mmHg.
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Individuals with current or recent systematic conditions, such as, acute kidney injury, or conditions that would mandate anticoagulation, such as a recent coronary stent.
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International Normalized Ratio (INR) < 1.5.
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Do Not Resuscitate (DNR) status; Do Not Intubate (DNI) status.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55901 |
| 2 | Mayo Clinic Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- Erbe USA Incorporated
Investigators
- Principal Investigator: Ryan Kern, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21-008716