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

Not Applicable

Completed

• Conditions: Lung Diseases, Obstructive; Lesions Mass; Bronchi--Diseases
• Interventions: Device: Cryoprobe biopsy; Procedure: Forceps biopsy

• Registration Number: NCT05399082
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-06-01
• Study Start: 2022-08-15
• Primary Completion: 2023-07-11
• Study Completion: 2023-07-11
• Results First Submitted: 2024-07-08
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Results First Posted: 2024-10-17
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Research cryoprobe biopsy then standard forceps biopsy	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 the cryoprobe first followed by forceps.
Standard forceps biopsy then research cryoprobe biopsy	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.
Standard forceps biopsy then research cryoprobe biopsy	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 forceps first followed by cryoprobe.
Research cryoprobe biopsy then standard forceps biopsy	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 specimens.
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 insufficient tissue and 4 being diagnostic material.
Total Histological Area	Pathology review, approximately 1 day	The total histological area of the biopsy samples. Measured in (mm\^2)
Crush Artifacts	Pathology review, approximately 1 day	The total percent area of crush artifacts identified in the biopsy samples (percent total area)
Other Pathologic Artifacts	Pathology review, approximately 1 day	The total percent area of other pathologic artifacts identified in the tissue biopsy samples that obscure pathological assessment (percent total area)
Different Tissue Types in the Tissue Specimen	Pathology review, approximately 1 day	The total percent area of different tissue types identified in the tissue biopsy samples. Defined as the total of alveoli, bronchus, mucus, blood, and target tissue (percent total area)

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States