Real World Registry for Use of the Ion Endoluminal System

Running, not enrolling

Conditions studied: Lung Cancer, Multiple Pulmonary Nodules, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases

In brief

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.

Key facts

Study ID

NCT06004440

Run by

Intuitive Surgical

People needed

1301

Starts

2023-09-21

Expected to finish

2028-08-01

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is 18 years or older at the time of the index procedure.
• Subject is a candidate for an elective, planned lung lesion localization or biopsy procedure utilizing the Ion Endoluminal System.
• Subject able to understand and adhere to study requirements and provide informed consent.

You may not qualify if…

• Subject is under the care of a Legally Authorized Representative (LAR) and is unable to provide informed consent on their own accord.
• Subject is participating in an interventional research study or research study investigational agents with an unknown safety profile that would interfere with participation in this study.
• Female subjects who are pregnant or nursing at the time of the index bronchoscopy procedure, as determined by standard site practices.
• Subjects that are incarcerated or institutionalized under court order, or other vulnerable populations.

Where it is running

• 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

Full record on ClinicalTrials.gov

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