Real World Registry for Use of the Ion Endoluminal System

Last updated: March 3, 2025
Sponsor: Intuitive Surgical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Non-small Cell Lung Cancer

Lung Cancer

Treatment

Ion Endoluminal System

Clinical Study ID

NCT06004440
IntuitiveSurgical
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 biopsyprocedure utilizing the Ion Endoluminal System.

  • Subject able to understand and adhere to study requirements and provide informedconsent.

Exclusion

Exclusion Criteria:

  • Subject is under the care of a Legally Authorized Representative (LAR) and is unableto provide informed consent on their own accord.

  • Subject is participating in an interventional research study or research studyinvestigational agents with an unknown safety profile that would interfere withparticipation in this study.

  • Female subjects who are pregnant or nursing at the time of the index bronchoscopyprocedure, as determined by standard site practices.

  • Subjects that are incarcerated or institutionalized under court order, or othervulnerable populations.

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: Ion Endoluminal System
Phase:
Study Start date:
September 21, 2023
Estimated Completion Date:
August 31, 2030

Study 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.

Connect with a study center

  • University of California Davis Medical Center

    Davis, California 95616
    United States

    Site Not Available

  • Orlando Health Orlando Regional Medical Center

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Ascension Alexian Brothers

    Elk Grove Village, Illinois 60007
    United States

    Active - Recruiting

  • Blessing Hospital

    Quincy, Illinois 62301
    United States

    Site Not Available

  • Kansas University Medical Center

    Kansas City, Kansas 66103
    United States

    Site Not Available

  • Tulane University

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55902
    United States

    Active - Recruiting

  • Mercy Hospital of Buffalo

    Buffalo, New York 14220
    United States

    Active - Recruiting

  • Atrium Health of the Carolinas

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Cone Health Moses Cone Memorial Hospital

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • FirstHealth Moore Regional Hospital

    Pinehurst, North Carolina 28374
    United States

    Site Not Available

  • Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Centennial Medical Center

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Methodist Hospital

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Intermountain Medical Center

    Murray, Utah 84107
    United States

    Active - Recruiting

  • Aurora Medical Center Kenosha

    Kenosha, Wisconsin 53143
    United States

    Site Not Available

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