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

Lung Cancer Clinical Trial

— ARTICULAtE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06308120
• Other study ID #: ISI-IONCN-002
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: April 2024
• Source: Intuitive Surgical
• Contact: Yueping Qian, Ph.D.
• Phone: 86-021-61892231
• Email: Katherine.qian[@]intufosun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: September 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Multiple Pulmonary Nodules
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Intervention

Device:
• Ion Endoluminal System
Participants in the test arm will undergo a diagnostic bronchoscopy with ION™ Endoluminal System.
• superDimension Navigation System and Accessories
Participants in the control arm will undergo a diagnostic bronchoscopy with superDimension Navigation System and Accessories.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Intuitive Surgical	Intuitive Surgical-Fosun Medical Technology (Shanghai) Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Incidence of intraoperative severe airway bleeding	Severe airway bleeding is defined as Grade 3 or above per Nashville Delphi scale (2020).	Intra-procedure