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
A lung nodule is a shadow identified on a computerised tomography (CT) scan which is an area of more dense tissue than normal lung tissue. Patients with nodules may require a sample of tissue (also known as a biopsy) to show whether this growth is benign (non-cancerous) or malignant (cancer). The results help to determine if treatment is required. These biopsies can be performed surgically or non-surgically. A possible non-surgical option is bronchoscopy where a flexible tube with a camera is passed though the mouth into the lungs.
The ION endoluminal system is a novel robotic bronchoscopy system designed to perform biopsies of lung nodules. It has a thin plastic tube (called a catheter) with sensors to provide information about its location in the airways. The catheter is then navigated to the nodule by the physician and tools are introduced into the catheter to take biopsies.
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.
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, then they will have further follow up at 6 and 13 months.
This is a prospective, interventional, multicentre, single arm study which will be conducted in England and will involve up to 200 patients
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