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

September 2, 2025 updated by: Intuitive Surgical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, E1 1FR
        • Barts Health NHS Trust
      • London, United Kingdom, SW3 6NP
        • Royal Brompton & Harefield Hospitals, Part of Guy'S and St Thomas' Nhs Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient is aged 18 years or older at time of consent.
  2. Patient is suitable for elective nodule biopsy via bronchoscopy under general anesthesia per Investigator's discretion.
  3. Patient has solid or semi-solid pulmonary nodule(s) of ≥6 mm and ≤3 cm in largest dimension (based on pre-procedure CT scan).
  4. Pulmonary nodule(s) intended for biopsy during the study procedure is (are) located at least 4 (≥4) airway generations out (trachea = generation 0, e.g. subsegmental bronchi or beyond) based on pre-procedure CT scan.
  5. Patient has a moderate to high risk of lung cancer based on clinical, demographic, and radiologic information or with suspected metastatic disease. High risk for malignancy patients are eligible if a biopsy is required or requested prior to intervention.
  6. Patient is willing and able to give written informed consent for Clinical Investigation participation.
  7. Patient is not legally incapacitated or in a legal/court ordered institution.

Exclusion Criteria:

  1. Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by Investigator prior to procedure.
  2. Patient with type 1 pure ground glass opacity target nodule(s) intended for biopsy during study procedure.
  3. Presence of mediastinal or hilar lymphadenopathy requiring tissue biopsy on pre-procedure CT or positron emission tomography (PET)-CT scan.
  4. Patient with American Society of Anesthesiologists Classification (ASA) ≥4.
  5. Patient underwent a pneumonectomy.
  6. Any invasive concomitant procedure not related to the pulmonary nodule(s) or suspected disease state.
  7. Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding.
  8. Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder.
  9. Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice.
  10. Patient is currently participating or has participated in another Clinical Investigation within the past 30 days, such as interventional trials or trials with experimental agents or agents of unknown risk, that may affect the endpoints of this Clinical Investigation.
  11. Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the Clinical Investigation.
  12. Patient is not willing to comply with post study procedure participation requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biopsy Arm
Patients undergoing biopsy with the Ion Endoluminal System
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tool in Nodule
Time Frame: At time of the biopsy procedure (Day 0)

Rate of achieving biopsy tool position within the targeted nodule(s), documented by means of intraprocedural 3D imaging.

Defined as how often the biopsy needle used to sample the tissue is positioned directly within the nodule before the sample is taken.

If biopsy forceps are used, it is how often the instrument is surrounding the nodule before the sample is taken
At time of the biopsy procedure (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of sample(s) obtained
Time Frame: Up to 13 months post procedure

Diagnostic accuracy will be calculated as the rate of diagnosis made using samples obtained during the study procedure (true positives and true negatives) relative to the number of cases performed.

Diagnostic yield may also be reported in conjunction with diagnostic accuracy and calculated as the rate of malignant and benign diagnosis made relative to the number of cases performed; non-diagnostic samples will not be included in the numerator.
Up to 13 months post procedure
Sensitivity for malignancy of sample(s) obtained
Time Frame: Up to 13 months post procedure
Sensitivity for malignancy of samples is assessed as the number of subjects with a malignant condition determined through the study procedure (true positives) relative to the number of subjects with an underlying malignant disease state (true positives + false negatives). The subjects underlying disease state will be determined by follow-up diagnostic interventions or treatment decisions/interventions, and/or radiographic follow-up.
Up to 13 months post procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of procedure-related Adverse Events through 30 days post-procedure
Time Frame: 30 days
The study's safety endpoint is the rate of procedure-related Adverse Events through 30 days post-procedure
30 days
Exploratory endpoint 1: Procedure-related characteristics
Time Frame: At time of the biopsy procedure (Day 0)
Procedure time (from catheter inserted into the patient's airways to catheter removed from the patient's airways) will be reported.
At time of the biopsy procedure (Day 0)
Exploratory endpoint 2:rEBUS visualization characteristics
Time Frame: At time of the biopsy procedure (Day 0)
The frequency of rEBUS visualization view during the biopsy will be summarized.
At time of the biopsy procedure (Day 0)
Exploratory endpoint 3: Biopsy workflow
Time Frame: At time of the biopsy procedure (Day 0)
The sequence of biopsy tools used will be summarized.
At time of the biopsy procedure (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuitive Surgical

Investigators

  • Study Director: Sundeep Master, Intuitive Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2023

Primary Completion (Actual)

April 11, 2024

Study Completion (Actual)

June 4, 2025

Study Registration Dates

First Submitted

April 21, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISI-ION-EU1-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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