Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Lung Diseases

Multiple Pulmonary Nodules

Respiratory Tract Diseases

Thoracic Neoplasms

Respiratory Tract Neoplasms

Subjects in which a pulmonary lesion biopsy, with or without localization, was attempted or performed with the Ion Endoluminal System.

Subjects will under a planned procedure with the Ion Endoluminal System

Ion Endoluminal System

Heather Golden, MSc, CCRP

Lindsay Seibel, BSc

Tina Tham, CCRP

Chinh Phan, DO

Kathleen Sanders, MBA, CCRP

Ali Z. Jiwani, MD

Diana Sullivan, MS, RN

Neeraj Desai, MD

Jamie Quigley, RRT, CCRC

Maykol Postigo, MD

Sherae Hereford, RN

A. Rolando Peralta, MD

Karly Pierson, RN, CCRP

Janani Reisenauer, MD

Iulia Basaraba, MD

Bradley Icard, DO

Julie Williams, PhD, MPH

Michael Prichett, DO, MPH

Amy Miller

Alberto Revelo, MD

Sean O'Malley, RN, BSN

Susan Garwood, MD

Samantha Franklin

Ali Abedi, MD, MSc

Valerie Aston, MBA, CCRP

Timothy LeClair, MD

Dina Yassen, MBBS

Hasnain Bawaadam, MD, MPH

Michael Pritchett, DO, MPH

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.

This study is a single-arm, post-market, prospective, multi-center, observational study of subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion localization or biopsy procedure with the Ion Endoluminal System. The primary outcome of this study is focused on evaluating the performance characteristics of the pulmonary lesion biopsy procedure as evaluated by diagnostic yield.

Clinical trial registration is submitted voluntarily under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60.

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

Defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only.

Defined as the incidence of subjects that undergo an Ion Procedure with a pneumothorax event, requiring intervention

Defined as the incidence of subjects that undergo an Ion Procedure with a bleeding event, with a grade of greater than 2 on the Nashville Scale

Intuitive Surgical

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Real World Registry for Use of the Ion Endoluminal System	NCT06004440	Lung Cancer Multiple Pulmon... Lung Neoplasms Respiratory Tra... Thoracic Neopla... Neoplasms by Si... Neoplasms Lung Diseases Respiratory Tra...	Ion Endoluminal...	18 Years -	Intuitive Surgical
Real World Registry for Use of the Ion Endoluminal System	NCT06004440	Lung Cancer Multiple Pulmon... Lung Neoplasms Respiratory Tra... Thoracic Neopla... Neoplasms by Si... Neoplasms Lung Diseases Respiratory Tra...	Ion Endoluminal...	18 Years -	Intuitive Surgical
Real World Registry for Use of the Ion Endoluminal System	NCT06004440	Lung Cancer Multiple Pulmon... Lung Neoplasms Respiratory Tra... Thoracic Neopla... Neoplasms by Si... Neoplasms Lung Diseases Respiratory Tra...	Ion Endoluminal...	18 Years -	Intuitive Surgical

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