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

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: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging

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, then they will have further follow up at 6 and 13 months.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carine Van den Abeele; Phone Number: +41 79 656 95 48; Email: Carine.vandenabeele@intusurg.com
• Study Contact Backup: Name: Martha Bean; Phone Number: +49 172 899 4278; Email: Martha.Bean@intusurg.com

Study Locations

• United Kingdom
  • London, United Kingdom, E1 1FR
    • Recruiting
    • Barts Health NHS Trust
    • Contact: Jacquline South; Email: jacquline.south@nhs.net
    • Principal Investigator: Kelvin KW Lau
  • London, United Kingdom, SW3 6NP
    • Recruiting
    • Royal Brompton & Harefield Hospitals, Part of Guy'S and St Thomas' Nhs Foundation Trust
    • Contact: Ley T Chan; Email: l.chan3@rbht.nhs.uk
    • Principal Investigator: Pallav L Shah
    • Sub-Investigator: Chris M Orton

Participation Criteria

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 bullae(s) with a size of >1 cm on pre-procedure CT scan located in close proximity to target nodule(s) and near the planned trajectory of the biopsy instruments.
4. Presence of mediastinal nodal disease on pre-procedure CT or positron emission tomography (PET)-CT scan.
5. Patient with American Society of Anesthesiologists Classification (ASA) ≥4.
6. Patient underwent a pneumonectomy.
7. Any invasive concomitant procedure (outside of lymph node staging) not related to the pulmonary nodule(s) or suspected disease state.
8. Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding.
9. Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder.
10. Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice.
11. 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.
12. Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the Clinical Investigation.
13. Patient is not willing to comply with post study procedure participation requirements.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

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	Rate of achieving biopsy tool position within the targeted nodule(s) 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	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	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	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	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	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	The sequence of biopsy tools used will be summarized.	At time of the biopsy procedure (Day 0)

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Study Director: Sundeep Master, Intuitive Surgical

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): May 31, 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 (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Bronchoscopy; Lung cancer; Biopsy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• 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