Lung Cancer Clinical Trial
Official title:
A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System
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.
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | August 2027 |
Est. primary completion date | August 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Wexner Medical Center | Columbus | Ohio |
United States | University of California Davis Medical Center | Davis | California |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Ascension Alexian Brothers | Elk Grove Village | Illinois |
United States | Cone Health Moses Cone Memorial Hospital | Greensboro | North Carolina |
United States | Kansas University Medical Center | Kansas City | Kansas |
United States | Aurora Medical Center Kenosha | Kenosha | Wisconsin |
United States | Intermountain Medical Center | Murray | Utah |
United States | Centennial Medical Center | Nashville | Tennessee |
United States | Orlando Health Orlando Regional Medical Center | Orlando | Florida |
United States | FirstHealth Moore Regional Hospital | Pinehurst | North Carolina |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Methodist Hospital | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Intuitive Surgical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Intra-procedure through the 24 month follow up period | |
Secondary | Secondary Endpoint to Assess Pneumothorax | Defined as the incidence of subjects that undergo an Ion Procedure with a pneumothorax event, requiring intervention | Intra-procedure through the 30 day follow up period | |
Secondary | 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 | Intra-procedure through the 30 day follow up period |
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