Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06308120
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-06
Brief Title:
A Trial to Compare Robotic Assisted Bronchoscopy Ions Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB
Sponsor:
Intuitive Surgical
Organization:
Intuitive Surgical
Study Overview
Official Title:
A Randomized Controlled Trial to Compare Robotic Assisted Bronchoscopy Ions Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARTICULAtE
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
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 537 More importantly these advanced bronchoscopic techniques havent 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 35 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
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 537 More importantly these advanced bronchoscopic techniques havent 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 35 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None