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

NCT05867953 | Completed

• 1 other identifier: ISI-ION-EU1-2022
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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. Data on safety will also be collected.

Conditions

Lung Cancer

Keywords

Lung cancer; Biopsy; Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Tool in Nodule

  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 Outcomes (2)

• Diagnostic accuracy of sample(s) obtained

  Up to 13 months post procedure

• Sensitivity for malignancy of sample(s) obtained

  Up to 13 months post procedure

Other Outcomes (4)

• Rate of procedure-related Adverse Events through 30 days post-procedure

  30 days

• Exploratory endpoint 1: Procedure-related characteristics

  At time of the biopsy procedure (Day 0)

• Exploratory endpoint 2:rEBUS visualization characteristics

  At time of the biopsy procedure (Day 0)

Study Arms (1)

Biopsy Arm

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 Adjunct Real-time Imaging

Biopsy Arm

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 mediastinal or hilar lymphadenopathy requiring tissue biopsy on pre-procedure CT or positron emission tomography (PET)-CT scan.
• Patient with American Society of Anesthesiologists Classification (ASA) ≥4.
• Patient underwent a pneumonectomy.
• Any invasive concomitant procedure 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 (2)

Barts Health Nhs Trust

London, E1 1FR, United Kingdom

Location

Royal Brompton & Harefield Hospitals, Part of Guy'S and St Thomas' Nhs Foundation Trust

London, SW3 6NP, United Kingdom

Location

Related Publications (1)

• Chan LT, Lau KKW, Orton CM, Temov K, Tana A, Baboolal I, Karir A, Agaoglu E, Garner J, Kalyal A, Lapuente M, Ttofia F, Shah PL. 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.

  PMID: 41391887 DERIVED

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, multi-center, single-arm, interventional study

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 22, 2023
• Study Start: April 20, 2023
• Primary Completion: April 11, 2024
• Study Completion: June 4, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)