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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Pulmonary Nodule, Solitary
• Intervention / Treatment: Device: Ion Endoluminal System; Device: superDimension Navigation System and Accessories

Detailed Description

Lung cancer is the malignant tumor with the highest morbidity and mortality in the world. Besides the aggressive nature of lung cancer, the overall high cancer mortality is mainly associated with the time delay between cancer development and initial clinical symptoms.

In the past, bronchoscope was mainly used to biopsy the nodules in the central airway but played a limited role in managing peripheral nodules due to its low diagnosis accuracy in such nodules. Advanced bronchoscopic techniques include tools for bronchoscopic guidance such as guide sheath (GS), Endobronchial Ultrasound (EBUS), Electromagnetic Navigation (ENB), or Virtual Bronchoscopic Navigation (VBN). In well-designed clinical studies, these techniques can be used to increase the diagnostic yield of flexible bronchoscope in dealing with peripheral nodules. However, the real-world registry study data showed that the diagnostic yield of these techniques in practice is as low as 53.7 %.. More importantly, these advanced bronchoscopic techniques haven't been widely used or become standard treatments in China mainly due to high skill requirements and high costs.

ION™ Endoluminal System is a robotic-assisted system which assists the user in navigating a catheter and endoscopic tools in the pulmonary tract under bronchial endoscope for diagnostic and therapeutic procedures. The fully articulating catheter with a small outer diameter of 3.5 mm can enter the small airways around the lungs with navigation enabled by shape-sensing technology and not electromagnetics; the shape sensing fiber provides instant feedbacks on shapes and locations during navigation and biopsy. The tool channel with an inner diameter of 2 mm for the catheter is compatible with various biopsy tools.

The purpose of this study a randomized controlled study to test the hypothesis that the diagnostic yield of ION™ is Superior to electromagnetic navigation bronchoscopy in patients undergoing bronchoscopy to biopsy a peripheral pulmonary nodule (PPN).

• Study Type: Interventional
• Enrollment (Estimated): 354
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yueping Qian, Ph.D.; Phone Number: 86-021-61892231; Email: Katherine.qian@intufosun.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Jiyuan Sun, M.D.
      • Principal Investigator: Jiyuan Sun, M.D.
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Zhongshan Hospital
      • Principal Investigator: Yuanlin Song, M.D.
      • Contact: Yuanlin Song, M.D.
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • West China Hospital
      • Contact: Dan Liu
      • Principal Investigator: Dan Liu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able to tolerate bronchoscopy;
2. ≥18 years and ≤ 80 years;
3. Chest CT scan results suggest one or more pulmonary nodules and suspected pulmonary malignant tumor which requires further diagnostic evaluation*;
4. The pulmonary nodules are solid or part-solid;
5. The maximum diameter of the whole nodule is >8 mm and ≤30 mm;
6. 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);
7. Able to understand and adhere to study requirements;
8. Able to provide and sign the informed consent form.

Exclusion Criteria:

1. The target nodule has been diagnosed as a malignant tumor or metastatic tumor;
2. 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;
3. Contraindications to bronchoscopy;
4. Contraindication to intubation, general anesthesia, or over American Society of Anesthesiologists (ASA) score of 3;
5. Known allergies, sensitivities, or previous allergic reactions to the disinfection reagents for reprocessing of the investigational product;
6. Pregnancy;
7. Any other condition that may increase the risk of bronchoscopic procedure as identified in the evaluation by the PI or bronchoscopist before bronchoscopic procedure;
8. Other conditions that the investigators consider not suitable for the subjects to participate in the study;
9. Participation in any other interventional or investigational clinical studies within 30 days before enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ION™ Endoluminal System; ION™ Endoluminal System Providers will utilize the ION™ Endoluminal System to perform a diagnostic bronchoscopy procedure	Device: Ion Endoluminal System; Participants in the test arm will undergo a diagnostic bronchoscopy with ION™ Endoluminal System.
Active Comparator: superDimension Navigation System and Accessories; Providers will utilize the superDimension Navigation System and Accessories to perform a diagnostic bronchoscopy procedure.	Device: superDimension Navigation System and Accessories; Participants in the control arm will undergo a diagnostic bronchoscopy with superDimension Navigation System and Accessories.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity for malignancy of biopsy obtained samples	Diagnostic sensitivity of malignancies=number of cases diagnosed with malignancies by study procedure / number of causes with malignancies in each group * 100 %	6 months post-procedure
Incidence of pneumothorax that requires chest tube placement and/or re-hospitalization or extended hospitalization	Pneumothorax is graded according to CTCAE 5.0. and differentiated according to the necessity to place a chest tube, readmission to the hospital, or prolonged hospitalization.	1 month post-procedure
Incidence of intraoperative severe airway bleeding	Severe airway bleeding is defined as Grade 3 or above per Nashville Delphi scale (2020).	Intra-procedure

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Collaborators: Intuitive Surgical-Fosun Medical Technology (Shanghai) Co., Ltd
• Investigators: Principal Investigator: Jiayuan Sun, M.D., Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
• Other Study ID Numbers: ISI-IONCN-002

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: Yes
• product manufactured in and exported from the U.S.: Yes