Real World Registry for Use of the Ion Endoluminal System

Sponsor

Intuitive Surgical (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06004440

Collaborator

(none)

3,000

Enrollment

Locations

Anticipated Duration (Months)

1000

Patients Per Site

21.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Multiple Pulmonary Nodules Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 31, 2023

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Primary Endpoint to Assess Diagnostic Yield [Intra-procedure through the 24 month follow up period]
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.

Secondary Outcome Measures

Secondary Endpoint to Assess Pneumothorax [Intra-procedure through the 30 day follow up period]
Defined as the incidence of subjects that undergo an Ion Procedure with a pneumothorax event, requiring intervention
Secondary Endpoint to Assess Bleeding [Intra-procedure through the 30 day follow up period]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orlando Health Orlando Regional Medical Center	Orlando	Florida	United States	32806
2	Mayo Clinic	Rochester	Minnesota	United States	55902
3	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina	United States	28374