A Study to Evaluate the Feasibility of Robotic Bronchoscopy-guided Miniature Cryoprobe Biopsy of Peripheral Pulmonary Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Ability to Successfully Obtain Sample
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
- •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.
- •Do Not Resuscitate (DNR) status; Do Not Intubate (DNI) status.
Arms & Interventions
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.
Intervention: Cryoprobe biopsy (Device)
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.
Intervention: Forceps biopsy (Procedure)
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.
Intervention: Cryoprobe biopsy (Device)
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.
Intervention: Forceps biopsy (Procedure)
Outcomes
Primary Outcomes
Ability to Successfully Obtain Sample
Time Frame: Baseline
Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis
Secondary Outcomes
- Histological Accessibility Grade(Pathology review, approximately 1 day)
- Duration of Biopsy Procedure(Biopsy procedure, approximately 3 hours)
- Freezing Time for Cryoprobe Biopsies(Biopsy procedure, approximately 60 seconds)
- Number of Successful Biopsy Attempts(Biopsy procedure, approximately 3 hours)
- Histological Diagnostic Yield(Pathology review, approximately 1 day)
- Total Histological Area(Pathology review, approximately 1 day)
- Crush Artifacts(Pathology review, approximately 1 day)
- Other Pathologic Artifacts(Pathology review, approximately 1 day)
- Different Tissue Types in the Tissue Specimen(Pathology review, approximately 1 day)
Investigators
Ryan M. Kern
Principal Investigator
Mayo Clinic