Lung Cancer, Lung Diseases, Lung Neoplasms, Multiple Pulmonary Nodules, Neoplasms, Neoplasms by Site, Respiratory Tract Diseases, Respiratory Tract Neoplasms, Thoracic Neoplasms
Conditions
Keywords
pulmonary biopsy, pulmonary lesion localization, shape sensing robotic assisted bronchoscopy, ION, Intuitive
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.
Interventions
DEVICEIon Endoluminal System
Subjects will under a planned procedure with the Ion Endoluminal System
Sponsors
Intuitive Surgical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Contacts
STUDY_CHAIRJanani Reisenauer, MD
Mayo Clinic
STUDY_CHAIRMichael Pritchett, DO, MPH
FirstHealth of the Carolinas
Outcome results
None listed