A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB

NCT06308120 | Recruiting FDA Device

• 1 other identifier: ISI-IONCN-002
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 3

Brief Summary

Multi-center randomized controlled study designed to compare the diagnostic yield of ION™ Endoluminal System with electromagnetic navigation bronchoscopy in patients undergoing transbronchial sampling procedure of peripheral pulmonary nodules.

Conditions

Pulmonary Nodule, Solitary; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic Yield

  Diagnostic yield=number of study procedures in which a true positive for malignancy or a specific benign result is diagnosed by biopsy or non-specific benign is confirmed at the follow-up 6 months after procedure/total number of study procedures of each group ×100 %

  6 months post-procedure

Secondary Outcomes (3)

• Sensitivity for malignancy of biopsy obtained samples

  6 months post-procedure

• Incidence of pneumothorax that requires chest tube placement and/or re-hospitalization or extended hospitalization

  1 month post-procedure

• Incidence of intraoperative severe airway bleeding

  Intra-procedure

Study Arms (2)

ION™ Endoluminal System

ACTIVE COMPARATOR

ION™ Endoluminal System Providers will utilize the ION™ Endoluminal System to perform a diagnostic bronchoscopy procedure

Device: Ion Endoluminal System

superDimension Navigation System and Accessories

ACTIVE COMPARATOR

Providers will utilize the superDimension Navigation System and Accessories to perform a diagnostic bronchoscopy procedure.

Device: superDimension Navigation System and Accessories

Interventions

Ion Endoluminal System DEVICE

Participants in the test arm will undergo a diagnostic bronchoscopy with ION™ Endoluminal System.

ION™ Endoluminal System

superDimension Navigation System and Accessories DEVICE

Participants in the control arm will undergo a diagnostic bronchoscopy with superDimension Navigation System and Accessories.

superDimension Navigation System and Accessories

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to tolerate bronchoscopy;
• ≥18 years and ≤ 80 years;
• Chest CT scan results suggest one or more pulmonary nodules and suspected pulmonary malignant tumor which requires further diagnostic evaluation\*;
• The pulmonary nodules are solid or part-solid;
• The maximum diameter of the whole nodule is \>8 mm and ≤30 mm;
• Chest CT scan results suggest peripheral nodules which are defined as nodules in the Generation 4 or above of the airway (trachea is defined as Generation 0, left and right principal bronchi as Generation 1, lobar bronchi as Generation 2, segmental bronchi as Generation 3, and subsegmental bronchi as Generation 4);
• Able to understand and adhere to study requirements;
• Able to provide and sign the informed consent form.

You may not qualify if:

• The target nodule has been diagnosed as a malignant tumor or metastatic tumor;
• The target nodule is later determined as a central lesion (the target nodule is in the airway, and not at a subsegmental or more distal location) during the bronchoscopy before the study procedure starts;
• Contraindications to bronchoscopy;
• Contraindication to intubation, general anesthesia, or over American Society of Anesthesiologists (ASA) score of 3;
• Known allergies, sensitivities, or previous allergic reactions to the disinfection reagents for reprocessing of the investigational product;
• Pregnancy;
• Any other condition that may increase the risk of bronchoscopic procedure as identified in the evaluation by the PI or bronchoscopist before bronchoscopic procedure;
• Other conditions that the investigators consider not suitable for the subjects to participate in the study;
• Participation in any other interventional or investigational clinical studies within 30 days before enrollment.

Sponsors & Collaborators

• Intuitive Surgical: lead
• Intuitive Surgical-Fosun Medical Technology (Shanghai) Co., Ltd: collaborator

Study Sites (3)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

West China Hospital

Chengdu, Sichuan, China

NOT YET RECRUITING

Related Publications (2)

• Liu D, Li C, Xie F, Hu X, Shi J, Liu Z, Liu J, Simoff MJ, Song Y, Sun J. Shape-sensing robotic-assisted bronchoscopy (ss-RAB) for peripheral pulmonary nodules: learning curve and diagnostic performance from an initial multicenter experience in China. Respir Res. 2026 Jan 26. doi: 10.1186/s12931-025-03488-z. Online ahead of print.

  PMID: 41588450 DERIVED

• Xie F, Zhang C, Li C, Liu D, Song Y, Simoff MJ, Sun J. Protocol for robotic-assisted bronchoscopy versus electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules: a randomized trial (ARTICULAtE study). J Thorac Dis. 2025 Jun 30;17(6):4339-4348. doi: 10.21037/jtd-2025-312. Epub 2025 Jun 26.

  PMID: 40688277 DERIVED

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jiayuan Sun, M.D.

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueping Qian, Ph.D.

CONTACT

86-021-61892231; Katherine.qian@intufosun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Pathologist reviewing biopsy results will be blinded
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Stratified, randomized controlled trial with parallel group assignment

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: March 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)