Spots Global Cancer Trial Database for Real World Registry for Use of the Ion Endoluminal System
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Trial Identification
Brief Title: Real World Registry for Use of the Ion Endoluminal System
Official Title: A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System
Study ID: NCT06004440
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California Davis Medical Center, Davis, California, United States
Orlando Health Orlando Regional Medical Center, Orlando, Florida, United States
Ascension Alexian Brothers, Elk Grove Village, Illinois, United States
Kansas University Medical Center, Kansas City, Kansas, United States
Henry Ford Hospital, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, 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
Contact Details
Name: Janani Reisenauer, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
Name: Michael Pritchett, DO, MPH
Affiliation: FirstHealth of the Carolinas
Role: STUDY_CHAIR
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