Real World Registry for Use of the Ion Endoluminal System

Recruiting

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

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Primary Endpoint to Assess Diagnostic Yield	Intra-procedure through the 24 month follow up period	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.

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint to Assess Bleeding	Intra-procedure through the 30 day follow up period	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
Secondary Endpoint to Assess Pneumothorax	Intra-procedure through the 30 day follow up period	Defined as the incidence of subjects that undergo an Ion Procedure with a pneumothorax event, requiring intervention

Locations (13): Methodist Hospital
🇺🇸
San Antonio, Texas, United States
University of California Davis Medical Center
🇺🇸
Davis, California, United States
Ascension Alexian Brothers
🇺🇸
Elk Grove Village, Illinois, United States
FirstHealth Moore Regional Hospital
🇺🇸
Pinehurst, North Carolina, United States
Cone Health Moses Cone Memorial Hospital
🇺🇸
Greensboro, North Carolina, United States
Ohio State University Wexner Medical Center
🇺🇸
Columbus, Ohio, United States
Aurora Medical Center Kenosha
🇺🇸
Kenosha, Wisconsin, United States
Intermountain Medical Center
🇺🇸
Murray, Utah, United States
Kansas University Medical Center
🇺🇸
Kansas City, Kansas, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
Centennial Medical Center
🇺🇸
Nashville, Tennessee, United States
Orlando Health Orlando Regional Medical Center
🇺🇸
Orlando, Florida, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States