N/A N=30 Randomized Other

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

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

Bottom Line

View on ClinicalTrials.gov: NCT05399082 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Ability to Successfully Obtain Sample — 123; 130 tissue samples

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cryoprobe biopsy (Device); Forceps biopsy (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Jul 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Ability to Successfully Obtain Sample	123; 130	—
SECONDARY Duration of Biopsy Procedure	41; 41	—
SECONDARY Freezing Time for Cryoprobe Biopsies	4.54	—
SECONDARY Number of Successful Biopsy Attempts	123; 130	—
SECONDARY Histological Accessibility Grade	—	—
SECONDARY Histological Diagnostic Yield	—	—
SECONDARY Total Histological Area	—	—
SECONDARY Crush Artifacts	—	—
SECONDARY Other Pathologic Artifacts	—	—
SECONDARY Different Tissue Types in the Tissue Specimen	—	—

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.

Eligibility Criteria

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05399082). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.