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

NCT06084208 | Active Not Recruiting

• 1 other identifier: ISI-ION-EU2-2023
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Lung Cancer; Biopsy; Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sensitivity for malignancy of sample(s) obtained

  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).

  At time of the biopsy procedure (Day 0)

Other Outcomes (4)

• Rate of procedure-related Adverse Events through 7 days post-procedure

  7 days

• Procedure-related characteristics

  At time of the biopsy procedure (Day 0)

• rEBUS visualization characteristics

  At time of the biopsy procedure (Day 0)

Study Arms (1)

Robotic Navigational Bronchoscopy

EXPERIMENTAL

Patients undergoing biopsy with the Ion Endoluminal System

Device: Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging

Interventions

Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging DEVICE

Biopsy with the Robotic- Navigational Bronchoscopy System with Cone Beam Computed Tomography (CBCT)

Robotic Navigational Bronchoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is aged 18 years or older at time of consent.
• Patient is suitable for elective nodule biopsy via bronchoscopy under general anesthesia per Investigator's discretion.
• Patient has solid or semi-solid pulmonary nodule(s) of ≥6 mm and ≤3 cm in largest dimension (based on pre-procedure CT scan).
• 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.
• 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.
• Patient is willing and able to give written informed consent for Clinical Investigation participation.
• Patient is not legally incapacitated or in a legal/court ordered institution.

You may not qualify if:

• Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by Investigator prior to procedure.
• Patient with type 1 pure ground glass opacity target nodule(s) intended for biopsy during study procedure.
• 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.
• Presence of mediastinal nodal disease on pre-procedure CT or PET-CT scan.
• Patient with American Society of Anesthesiologists Classification (ASA) ≥4.
• Patient underwent a pneumonectomy.
• Any invasive concomitant procedure (outside of lymph node staging) not related to the pulmonary nodule(s) or suspected disease state.
• Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding.
• Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder.
• Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice.
• 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.
• Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the Clinical Investigation.
• Patient is not willing to comply with post study procedure participation requirements.

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (1)

Radboud University Medical Center

Nijmegen, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sundeep Master

  Intuitive Surgical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, single-center, dual-arm, interventional study, where data from 131 recruited patients undergoing a Robotic Navigational Bronchoscopy System procedure with CBCT are compared to 91 matched Navigation Bronchoscopy with CBCT controls.

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 16, 2023
• Study Start: September 15, 2023
• Primary Completion: January 24, 2025
• Study Completion: March 31, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)