NCT05399082

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

Completed NA Results posted Last updated 17 October 2024

What this trial tests

NA trial testing Cryoprobe biopsy in Bronchi--Diseases in 30 participants. Completed in 11 July 2023.

Timeline

15 August 2022

Primary endpoint
11 July 2023

11 July 2023

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	30
Start date	15 August 2022
Primary completion	11 July 2023
Estimated completion	11 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Cryoprobe biopsy
• Forceps biopsy

Conditions studied

• Bronchi--Diseases — all drugs for Bronchi--Diseases →
• Lung Diseases, Obstructive — all drugs for Lung Diseases, Obstructive →
• Lesions Mass — all drugs for Lesions Mass →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Bronchi--Diseases or Lung Diseases, Obstructive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Ability to Successfully Obtain Sample Primary · Baseline

Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis

Group	Value	95% CI
Standard Forceps Biopsy	123
Research Cryoprobe Biopsy	130

Duration of Biopsy Procedure Secondary · Biopsy procedure, approximately 3 hours

Total time of biopsy procedure from first insertion of probe into robotic sheath to removal of specimens.

Group	Value	95% CI
Standard Forceps Biopsy	41	30 – 53
Research Cryoprobe Biopsy	41	21 – 54

Freezing Time for Cryoprobe Biopsies Secondary · Biopsy procedure, approximately 60 seconds

Total freezing time for cryoprobe biopsies, measured in seconds

Group	Value	95% CI
Research Cryoprobe Biopsy	4.54	± 0.91

Number of Successful Biopsy Attempts Secondary · 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.

Group	Value	95% CI
Standard Forceps Biopsy	123
Research Cryoprobe Biopsy	130

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for each subject from baseline until completion of the standard of care post procedure follow-up for approximately 2 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard Forceps Biopsy

Serious: 0/30 (0%)

Deaths: 0/30

Research Cryoprobe Biopsy

Serious: 0/30 (0%)

Deaths: 0/30

Other adverse events (1 terms — click to expand)

Reaction	System	Standard Forceps Biopsy	Research Cryoprobe Biopsy
Minor bleeding	Injury, poisoning and procedural complications	—	—

Data from ClinicalTrials.gov NCT05399082 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Real-World Impact of Robotic-Assisted Bronchoscopy on the Staging and Diagnosis of Lung Cancer: The Shape of Current and Potential Opportunities.
   Ortiz-Jaimes G, Reisenauer J. · · 2023 · cited 9× · PMID 37694262 · DOI 10.2147/por.s395806