RecruitingNot ApplicableNCT06308120

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

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


Sponsor

Intuitive Surgical

Enrollment

354 participants

Start Date

Mar 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares two methods for reaching and taking a tissue sample (biopsy) from small lung nodules — suspicious spots in the outer part of the lung. One method uses a robotic bronchoscope (a flexible tube guided by a robot), and the other uses an older navigation system. The goal is to find out which approach is more accurate. **You may be eligible if...** - You are between 18 and 80 years old - A CT scan has found one or more small suspicious spots in your lungs that need further evaluation - The nodule is solid or partly solid and is between 8 mm and 30 mm in size - The nodule is located in the outer sections of your lungs - You are able to tolerate a bronchoscopy (a camera-guided procedure into the airways) **You may NOT be eligible if...** - The nodule has already been diagnosed as cancer - You are pregnant - You have conditions that make bronchoscopy or general anesthesia unsafe - You participated in another clinical study in the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIon Endoluminal System

Participants in the test arm will undergo a diagnostic bronchoscopy with ION™ Endoluminal System.

DEVICEsuperDimension Navigation System and Accessories

Participants in the control arm will undergo a diagnostic bronchoscopy with superDimension Navigation System and Accessories.


Locations(3)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

West China Hospital

Chengdu, Sichuan, China

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NCT06308120


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