Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Subjects with biopsy, with or without localization, of pulmonary lesion using Ion Endoluminal System Subjects in which a pulmonary lesion biopsy, with or without localization, was attempted or performed with the Ion Endoluminal System.
  • Device: Ion Endoluminal System
    Subjects will under a planned procedure with the Ion Endoluminal System

Recruiting Locations

Tulane University
New Orleans, Louisiana 70112
Contact:
Christine Glynn

More Details

Status
Recruiting
Sponsor
Intuitive Surgical

Study Contact

Heather Golden, MSc, CCRP
8105697006
heather.golden@intusurg.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.