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

Last updated: April 2, 2024
Sponsor: Intuitive Surgical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Pulmonary Nodules

Lung Disease

Treatment

superDimension Navigation System and Accessories

Ion Endoluminal System

Clinical Study ID

NCT06308120
ISI-IONCN-002
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 pulmonarymalignant 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 theGeneration 4 or above of the airway (trachea is defined as Generation 0, left andright principal bronchi as Generation 1, lobar bronchi as Generation 2, segmentalbronchi 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

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 theairway, and not at a subsegmental or more distal location) during the bronchoscopybefore the study procedure starts;
  3. Contraindications to bronchoscopy;
  4. Contraindication to intubation, general anesthesia, or over American Society ofAnesthesiologists (ASA) score of 3;
  5. Known allergies, sensitivities, or previous allergic reactions to the disinfectionreagents for reprocessing of the investigational product;
  6. Pregnancy;
  7. Any other condition that may increase the risk of bronchoscopic procedure asidentified in the evaluation by the PI or bronchoscopist before bronchoscopicprocedure;
  8. Other conditions that the investigators consider not suitable for the subjects toparticipate in the study;
  9. Participation in any other interventional or investigational clinical studies within 30 days before enrollment.

Study Design

Total Participants: 354
Treatment Group(s): 2
Primary Treatment: superDimension Navigation System and Accessories
Phase:
Study Start date:
March 20, 2024
Estimated Completion Date:
September 30, 2026

Study 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).

Connect with a study center

  • Shanghai Chest Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Zhongshan Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • West China Hospital

    Chengdu, Sichuan
    China

    Site Not Available

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