NCT05867953

Assessment of Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System

A Prospective Investigation to Assess the Accurate Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System With Adjunct Real-time Imaging

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (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. Data on safety will also be collected.

Detailed description

This is a prospective, interventional, multicentre, single arm study which will be conducted in Europe and will involve up to 200 patients undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with 3D imaging. The objectives of the study are focused on evaluating the procedure characteristics of the pulmonary nodule biopsy procedure, including rate of tool in nodule, diagnostic accuracy, sensitivity for malignancy and safety. All subjects will be followed up at 1 week and 1 month after the procedure. If the biopsy did not provide a diagnosis or did not show cancer and was still under observation at the 1 month visit, then they will have further follow up at 6 months. Similarly, if the status is unchanged (non-malignant diagnosis) at 6 months, the patients 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 Adjunct Real-time Imaging

Timeline

• Start date: 2023-04-20
• Primary completion: 2024-04-11
• Completion: 2025-06-04
• First posted: 2023-05-22
• Last updated: 2025-09-08

Locations

2 sites across 1 country: United Kingdom