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
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
Summary of results
1. Title of study
“A Prospective Investigation to Assess the Accurate Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System With Adjunct Real-time Imaging”, i.e. Assessing how accurately a new robotic bronchoscopy system can reach and sample small lung nodules.
2. What was the purpose of this study?
Small lung nodules are now found more often because of increased CT scanning and lung cancer screening. When these nodules appear suspicious, doctors usually need to take a small tissue sample (a biopsy) to find out whether they are cancerous.
Traditional biopsy methods can sometimes be inaccurate or carry risks such as lung collapse (pneumothorax). This study looked at a new type of robotic bronchoscopy system called the Ion Endoluminal System, which is designed to help doctors reach very small nodules deep inside the lung in a controlled and precise way. The main question was: How often can this system accurately place the biopsy tool inside the lung nodule?
The study also looked at:
• How often the biopsy gave a clear diagnosis
• How safe the procedure was
• What the overall patient pathway looked like (e.g., procedure time, need for more tests)
3. Who took part?
• 200 adult patients across two hospitals in the United Kingdom
• All participants had small peripheral lung nodules (6–30 mm) that required biopsy
• Most participants were former or current smokers, which is typical for this population
4. What did the study involve?
Participants underwent a bronchoscopy under general anesthetic. During the procedure:
1. Doctors used the Ion robotic catheter to navigate to the lung nodule using a pre planned route.
2. Cone-beam CT scanning (a type of 3D imaging performed during the procedure) was used to check the biopsy tool positioned inside the nodule.
3. Doctors collected samples using biopsy needles or forceps.
4. Participants returned for follow up at 1 week, 1 month, and—if their biopsy initially showed no cancer—again at 6 and 13 months.
5. What were the main results?
Accuracy
• The robotic system successfully placed the biopsy tool inside the target nodule in 99% of cases.
• In most cases (over 90%), the tool reached the centre of the nodule, which increases the chance of an accurate result.
Diagnostic performance
• 85% of patients received a clear diagnosis from the biopsy.
• When long term follow up (13 months) was included, overall diagnostic accuracy was 92%.
• For nodules that were cancerous, the test correctly identified them 95% of the time.
Safety
Most side effects were mild and expected for this type of procedure:
• One patient experienced a pneumothorax (collapsed lung) requiring a small chest tube.
• Five serious complications occurred across four patients, but none were caused by a device malfunction.
• Small amounts of bleeding during or after the biopsy occurred in 13% of patients.
• One patient in the study died, but this was related to their advanced underlying cancer, not the procedure.
Overall, the complication rate was lower than what is typically seen with CT-guided lung biopsies, which are known to carry a higher risk of lung collapse.
6. What do these results mean?
The study suggests that the Ion robotic bronchoscopy system can:
• Accurately reach small, hard to access lung nodules
• Provide a reliable diagnosis
• Do so with a lower complication rate compared to some existing biopsy methods
This is important because getting an accurate diagnosis early can help patients receive appropriate treatment sooner.
7. What were the study limitations?
• The study did not compare the robotic system directly with other biopsy techniques.
• All procedures were done at specialist centres with experienced teams, so results might differ in other settings.
• Most patients in the study ultimately had cancer, which may make the diagnostic performance appear higher than in a more general population.
8. Who funded and ran the study?
The study was sponsored by Intuitive Surgical, Inc., the manufacturer of the Ion endoluminal system.
It took place at:
• Royal Brompton & Harefield Hospitals (London)
• Barts Health NHS Trust (London)
Ethics approvals were obtained before the study began.
9. Where can I learn more?
This is a summary of the manuscript by Chan LT and others: Tool in lesion verification of shape-sensing robotic-assisted bronchoscopy with cone beam CT in sampling peripheral pulmonary nodules. Thorax. 2025 Dec 18:thorax-2025-223631. doi: 10.1136/thorax-2025-223631. Online ahead of print.The study is registered under:
• ClinicalTrials.gov ID: NCT05867953
• IRAS number: 308868REC 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