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.
Study Type
OBSERVATIONAL
Enrollment
3,000
Subjects will under a planned procedure with the Ion Endoluminal System
Orlando Health Orlando Regional Medical Center
Orlando, Florida, United States
RECRUITINGAscension Alexian Brothers
Elk Grove Village, Illinois, United States
RECRUITINGBlessing Hospital
Quincy, Illinois, United States
RECRUITINGKansas University Medical Center
Kansas City, Kansas, United States
ACTIVE_NOT_RECRUITINGTulane University
New Orleans, Louisiana, United States
RECRUITINGHenry Ford Hospital
Detroit, Michigan, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGMercy Hospital of Buffalo
Buffalo, New York, United States
RECRUITINGAtrium Health of the Carolinas
Charlotte, North Carolina, United States
RECRUITINGCone Health Moses Cone Memorial Hospital
Greensboro, North Carolina, United States
ACTIVE_NOT_RECRUITING...and 6 more locations
Primary Endpoint to Assess Diagnostic Yield
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.
Time frame: Intra-procedure through the 24 month follow up period
Secondary Endpoint to Assess Pneumothorax
Defined as the incidence of subjects that undergo an Ion Procedure with a pneumothorax event, requiring intervention
Time frame: Intra-procedure through the 30 day follow up period
Secondary Endpoint to Assess Bleeding
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
Time frame: Intra-procedure through the 30 day follow up period
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