N/A
Completed N=30
Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe
Bronchi--Diseases · Lung Diseases, Obstructive · Lesions Mass
Source: ClinicalTrials.gov NCT05399082 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Ability to Successfully Obtain Sample — 123; 130 tissue samples
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.
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 |
— | — |
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.
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. Informational only — not medical advice.