Tool Placement in Pulmonary Nodule using a Robotic Bronchoscopy System
Research type
Research Study
Full title
A Prospective Investigation to Assess the Accurate Tool Placement in Pulmonary Nodule(s) using a Robotic Navigational Bronchoscopy System with Adjunct Real-time Imaging
IRAS ID
308868
Contact name
Pallav L. Shah
Contact email
Sponsor organisation
Intuitive Surgical, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 29 days
Research summary
This is a prospective, interventional, multi-centre, single arm study to evaluate the rate of tool in nodule(s) using the Ion Endoluminal System when used in combination with 3D imaging methods for the biopsy of peripheral pulmonary nodules (PPNs). The Ion Endoluminal System is an apparatus that is used to navigate a flexible catheter inside the lung on a planned pathway, to biopsy a peripheral lung nodule. It is indicated for use in patients that require a sampling of nodules identified in their lung, to determine whether these nodules are cancerous. \nThe study will include up to 200 patients from the United Kingdom and The Netherlands. Patients identified to have pulmonary nodule(s) suitable for a tissue biopsy will be screened for study participation. \nThe Ion Endoluminal system is produced by the company Intuitive and the primary objective of this study is to evaluate the rate of Tool in Nodule(s) when used in combination with 3D imaging methods. The total study duration is 28 months, 12 months enrolment, a follow up phase of up approximately 13 months and a data analysis phase of 3 months. Individual patients will be involved in the study for up to 13 months and will have up to 7 visits to the hospital (1 visit each for the screening and pre-procedure assessments, 1 visit for the procedure and up to 4 follow up visits). The 4 follow up visits may be performed in person or via telehealth visits. Patients will only be contacted for the 3rd and 4th follow up visit if the sample is non-diagnostic or benign.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0271
Date of REC Opinion
22 Dec 2022
REC opinion
Further Information Favourable Opinion