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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Device: Cryoprobe biopsy
* Procedure: Forceps biopsy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard forceps biopsy then research cryoprobe biopsy<br>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<br>* A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue<br>Procedure: Forceps biopsy<br>* Biopsy forceps used to collect tissue<br>|
| Experimental: Research cryoprobe biopsy then standard forceps biopsy<br>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<br>* A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue<br>Procedure: Forceps biopsy<br>* Biopsy forceps used to collect tissue<br>|

What is the study measuring?
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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 |