Assessment of Diagnostic Yield Using a Robotic Navigational Bronchoscopy System With CBCT

A Prospective Investigation to Assess the Diagnostic Yield of 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. The learning curve of the procedure will be assessed and data on safety will also be collected.

Study Overview

• Status: Active, not 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, single-centre, dual-arm study which will be conducted in the Netherlands and will involve up to 131 patients undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with 3D imaging. Outcomes in these patients will be compared to 91 propensity score matched Cone Beam CT- Navigational Bronchoscopy (CBCT-NB) controls obtained from the site's existing CBCT-NB database.

The objectives of the study are focused on evaluating the procedure learning curve and characteristics of the pulmonary nodule biopsy procedure, including diagnostic yield, rate of tool in nodule, sensitivity for malignancy and safety.

A learning curve analysis will be retrospectively performed to determine when both operators have reached competency with the Ion Endoluminal System. Criteria for passing the learning curve for measuring proficiency in the CUSUM will be diagnostic yield. Additional parameters like tool in lesion and procedure durations will also be monitored.

All subjects will be followed up at 1 week after the procedure. If an adverse event was observed, a 30-day post-procedure visit will also take place. If the biopsy did not provide a diagnosis or did not show cancer and was still under observation, then they will have further follow up at 6 months. Similarly, if the status is unchanged (non-malignant diagnosis) and the nodule is still under observation, a 13 months visit should be completed.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6500 HB
    • Radboud University Medical Center

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 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: Robotic Navigational Bronchoscopy; 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 Cone Beam Computed Tomography (CBCT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield of sample(s) obtained (post learning curve)	Diagnostic yield is the number of nodules in which the procedure was diagnostic (either malignant or non-malignant), relative to the total number of attempted navigation procedures	Up to 13 months post procedure]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rate of achieving biopsy tool position within the targeted nodule(s) as confirmed by CBCT 3D imaging or the combination of multi-angle augmented fluoroscopy with diagnostic rapid onsite pathology (in the absence of a confirmatory spin).	The rate of Tool in Nodule is how often the biopsy tool 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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
rEBUS visualization characteristics	The frequency of use of a concentric rEBUS visualization view during the biopsy will be summarized.	At time of the biopsy procedure (Day 0)
Biopsy workflow	The sequence of biopsy tools used will be summarized.	At time of the biopsy procedure (Day 0)
Rate of procedure-related Adverse Events through 7 days post-procedure	The study's safety endpoint is the rate of procedure-related Adverse Events through 7 days post-procedure	7 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): January 24, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Lung Cancer; Bronchoscopy; Biopsy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Cytodiagnosis; Diagnostic Techniques, Surgical; Biopsy
• Other Study ID Numbers: ISI-ION-EU2-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD.

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