Real World Registry for Use of the Ion Endoluminal System

Intuitive Surgical

Status: Enrolling

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

Treatments: Device: Ion Endoluminal System

Study type: Observational

Funder types: Industry

Identifiers

NCT06004440

IntuitiveSurgical

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

3,000 participants in 1 patient group

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

Description:

Subjects in which a pulmonary lesion biopsy, with or without localization, was attempted or performed with the Ion Endoluminal System.

Treatment:

Device: Ion Endoluminal System