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

Mayo Clinic

Status: Completed

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

Treatments: Device: Cryoprobe biopsy; Procedure: Forceps biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05399082

21-008716

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Standard forceps biopsy then research cryoprobe biopsy

Experimental group

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.

Treatment:

Procedure: Forceps biopsy

Device: Cryoprobe biopsy

Research cryoprobe biopsy then standard forceps biopsy

Experimental group

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.

Treatment:

Procedure: Forceps biopsy

Device: Cryoprobe biopsy