Real World Registry for Use of the Ion Endoluminal System

Lung Cancer Clinical Trial

Official title:

A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06004440
• Other study ID #: IntuitiveSurgical
• Status: Recruiting
• Start date: September 21, 2023
• Est. completion date: August 2027

Study information

• Verified date: March 2024
• Source: Intuitive Surgical
• Contact: Heather Golden, MSc, CCRP
• Phone: 8105697006
• Email: heather.golden[@]intusurg.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: August 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Ion Endoluminal System
Subjects will under a planned procedure with the Ion Endoluminal System

Locations

Country	Name	City	State
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	University of California Davis Medical Center	Davis	California
United States	Henry Ford Hospital	Detroit	Michigan
United States	Ascension Alexian Brothers	Elk Grove Village	Illinois
United States	Cone Health Moses Cone Memorial Hospital	Greensboro	North Carolina
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Aurora Medical Center Kenosha	Kenosha	Wisconsin
United States	Intermountain Medical Center	Murray	Utah
United States	Centennial Medical Center	Nashville	Tennessee
United States	Orlando Health Orlando Regional Medical Center	Orlando	Florida
United States	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	Methodist Hospital	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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