RecruitingNCT06004440

Real World Registry for Use of the Ion Endoluminal System

A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System

Sponsor

Intuitive Surgical

Enrollment

3,000 participants

Start Date

Sep 21, 2023

Study Type

OBSERVATIONAL

Conditions

Lung Cancer Lung Neoplasms Neoplasms Neoplasms by Site Thoracic Neoplasms Respiratory Tract Neoplasms Lung Diseases Respiratory Tract Diseases Multiple Pulmonary Nodules

Summary

The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry study is collecting real-world data on the Ion Endoluminal System, a robotic bronchoscopy tool used to navigate and biopsy hard-to-reach spots in the lung to check for early-stage lung cancer. **You may be eligible if:** - You are 18 or older - Your doctor has recommended a lung biopsy or lesion localization using the Ion system - You are able to understand and agree to study requirements **You may NOT be eligible if:** - You cannot give consent on your own (require a legal representative) - You are pregnant or nursing - You are incarcerated or institutionalized - You are already in another interventional study with an unknown safety profile 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

Subjects will under a planned procedure with the Ion Endoluminal System

Locations(16)

Orlando Health Orlando Regional Medical Center

Orlando, Florida, United States

Ascension Alexian Brothers

Elk Grove Village, Illinois, United States

Blessing Hospital

Quincy, Illinois, United States

Kansas University Medical Center

Kansas City, Kansas, United States

Tulane University

New Orleans, Louisiana, United States

Henry Ford Hospital

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Mercy Hospital of Buffalo

Buffalo, New York, United States

Atrium Health of the Carolinas

Charlotte, North Carolina, United States

Cone Health Moses Cone Memorial Hospital

Greensboro, North Carolina, United States

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Centennial Medical Center

Nashville, Tennessee, United States

Methodist Hospital

San Antonio, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

Aurora Medical Center Kenosha

Kenosha, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06004440

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