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

Lung Diseases, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05399082
• Other study ID #: 21-008716
• Status: Completed
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: July 11, 2023

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 11, 2023
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Erbe USA Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to successfully obtain sample	Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis	Baseline
Secondary	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
Secondary	Freezing time for cryoprobe biopsies	Total freezing time for cryoprobe biopsies, measured in seconds	Biopsy procedure, approximately 60 seconds
Secondary	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
Secondary	Histological accessibility grade	Pathologic description ranging from insufficient to diagnostic material	Pathology review, approximately 1 day
Secondary	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
Secondary	Total histological area (mm^2)		Pathology review, approximately 1 day
Secondary	Crush artifacts (percent total area)		Pathology review, approximately 1 day
Secondary	Other pathologic artifacts present in the tissue that obscure pathological assessment (percent total area)		Pathology review, approximately 1 day
Secondary	Different tissue types in the tissue specimen	alveoli, bronchus, mucus, blood, target tissue; % total area	Pathology review, approximately 1 day

External Links

•   Mayo Clinic Clinical Trials