Real World Registry for Use of the Ion Endoluminal System

NCT06004440 | Active Not Recruiting FDA Device

• 1 other identifier: ISI-ION-003
• Study Type: observational
• Target: 1,301
• Locations: 1 country
• Sites: 16

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.

Conditions

Lung Neoplasms; Respiratory Tract Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Thoracic Neoplasms; Lung Cancer; Multiple Pulmonary Nodules

Keywords

pulmonary biopsy; pulmonary lesion localization; shape sensing robotic assisted bronchoscopy; ION; Intuitive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Secondary Endpoint to Assess Pneumothorax

  Intra-procedure through the 30 day follow up period

• Secondary Endpoint to Assess Bleeding

  Intra-procedure through the 30 day follow up period

Study Arms (1)

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

Interventions

Ion Endoluminal System DEVICE

Subjects will under a planned procedure with the Ion Endoluminal System

Subjects with biopsy, with or without localization, of pulmonary lesion using Ion Endoluminal System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (16)

Orlando Health Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Ascension Alexian Brothers

Elk Grove Village, Illinois, 60007, United States

Location

Blessing Hospital

Quincy, Illinois, 62301, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66103, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Mercy Hospital of Buffalo

Buffalo, New York, 14220, United States

Location

Atrium Health of the Carolinas

Charlotte, North Carolina, 28203, United States

Location

Cone Health Moses Cone Memorial Hospital

Greensboro, North Carolina, 27401, United States

Location

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Methodist Hospital

San Antonio, Texas, 78229, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Aurora Medical Center Kenosha

Kenosha, Wisconsin, 53143, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Multiple Pulmonary Nodules; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Janani Reisenauer, MD

  Mayo Clinic

  STUDY CHAIR

• Michael Pritchett, DO, MPH

  FirstHealth of the Carolinas

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 22, 2023
• Study Start: September 21, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)