Real World Registry for Use of the Ion Endoluminal System

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neoplasms; Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Multiple Pulmonary Nodules; Lung Cancer
• Intervention / Treatment: Device: Ion Endoluminal System

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.

• Study Type: Observational
• Enrollment (Actual): 1301

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health Orlando Regional Medical Center
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Ascension Alexian Brothers
    • Quincy, Illinois, United States, 62301
      • Blessing Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • Kansas University Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • New York
    • Buffalo, New York, United States, 14220
      • Mercy Hospital of Buffalo
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health of the Carolinas
    • Greensboro, North Carolina, United States, 27401
      • Cone Health Moses Cone Memorial Hospital
    • Pinehurst, North Carolina, United States, 28374
      • Firsthealth Moore Regional Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Wexner Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Centennial Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53143
      • Aurora Medical Center Kenosha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects scheduled for an elective pulmonary lesion biopsy or localization procedure using the Ion Endoluminal System, 18 years or older

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Study Chair: Janani Reisenauer, MD, Mayo Clinic; Study Chair: Michael Pritchett, DO, MPH, FirstHealth of the Carolinas

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pulmonary biopsy; pulmonary lesion localization; shape sensing robotic assisted bronchoscopy; ION; Intuitive
• Additional Relevant MeSH Terms: Neoplasms; Lung Diseases; Lung Neoplasms; Respiratory Tract Diseases; Thoracic Neoplasms; Respiratory Tract Neoplasms; Neoplasms by Site; Multiple Pulmonary Nodules
• Other Study ID Numbers: ISI-ION-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No