NCT06084208

Assessment of Diagnostic Yield Using a Robotic Navigational Bronchoscopy System With CBCT

A Prospective Investigation to Assess the Diagnostic Yield of Using a Robotic Navigational Bronchoscopy System With Adjunct Real-time Imaging

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this research study is to evaluate the effectiveness of the ION endoluminal system at reaching and obtaining biopsies from lung nodules when used in combination with 3-dimensional imaging such as CT scans. The learning curve of the procedure will be assessed and data on safety will also be collected.

Detailed description

This is a prospective, interventional, single-centre, dual-arm study which will be conducted in the Netherlands and will involve up to 131 patients undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with 3D imaging. Outcomes in these patients will be compared to 91 propensity score matched Cone Beam CT- Navigational Bronchoscopy (CBCT-NB) controls obtained from the site's existing CBCT-NB database. The objectives of the study are focused on evaluating the procedure learning curve and characteristics of the pulmonary nodule biopsy procedure, including diagnostic yield, rate of tool in nodule, sensitivity for malignancy and safety. A learning curve analysis will be retrospectively performed to determine when both operators have reached competency with the Ion Endoluminal System. Criteria for passing the learning curve for measuring proficiency in the CUSUM will be diagnostic yield. Additional parameters like tool in lesion and procedure durations will also be monitored. All subjects will be followed up at 1 week after the procedure. If an adverse event was observed, a 30-day post-procedure visit will also take place. If the biopsy did not provide a diagnosis or did not show cancer and was still under observation, then they will have further follow up at 6 months. Similarly, if the status is unchanged (non-malignant diagnosis) and the nodule is still under observation, a 13 months visit should be completed.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging	Biopsy with the Robotic- Navigational Bronchoscopy System with Cone Beam Computed Tomography (CBCT)

Timeline

• Start date: 2023-09-15
• Primary completion: 2025-01-24
• Completion: 2026-03-31
• First posted: 2023-10-16
• Last updated: 2025-09-05

Locations

1 site across 1 country: Netherlands