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Trial Title:
A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB
NCT ID:
NCT06308120
Condition:
Pulmonary Nodule, Solitary
Lung Cancer
Conditions: Official terms:
Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Stratified, randomized controlled trial with parallel group assignment
Primary purpose:
Diagnostic
Masking:
Single (Outcomes Assessor)
Masking description:
Pathologist reviewing biopsy results will be blinded
Intervention:
Intervention type:
Device
Intervention name:
Ion Endoluminal System
Description:
Participants in the test arm will undergo a diagnostic bronchoscopy with ION™ Endoluminal
System.
Arm group label:
ION™ Endoluminal System
Intervention type:
Device
Intervention name:
superDimension Navigation System and Accessories
Description:
Participants in the control arm will undergo a diagnostic bronchoscopy with
superDimension Navigation System and Accessories.
Arm group label:
superDimension Navigation System and Accessories
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.
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).
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiyuan Sun, M.D.
Investigator:
Last name:
Jiyuan Sun, M.D.
Email:
Principal Investigator
Facility:
Name:
Zhongshan Hospital
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yuanlin Song, M.D.
Investigator:
Last name:
Yuanlin Song, M.D.
Email:
Principal Investigator
Facility:
Name:
West China Hospital
Address:
City:
Chengdu
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Dan Liu
Investigator:
Last name:
Dan Liu, M.D.
Email:
Principal Investigator
Start date:
March 20, 2024
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Intuitive Surgical
Agency class:
Industry
Collaborator:
Agency:
Intuitive Surgical-Fosun Medical Technology (Shanghai) Co., Ltd
Agency class:
Other
Source:
Intuitive Surgical
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06308120
