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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06004440
Other study ID # IntuitiveSurgical
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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