Real World Registry for Use of the Ion Endoluminal System

N/AActive Not RecruitingNCT06004440

Intuitive Surgical1,301 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

1,301

Conditions

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

Interventions

Ion Endoluminal SystemDEVICE

Subjects will under a planned procedure with the Ion Endoluminal System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

Orlando Health Orlando Regional Medical Center

Orlando, Florida, United States

Ascension Alexian Brothers

Elk Grove Village, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: Intra-procedure through the 24 month follow up period

Secondary Outcomes

Secondary Endpoint to Assess Pneumothorax

Defined as the incidence of subjects that undergo an Ion Procedure with a pneumothorax event, requiring intervention

Time frame: Intra-procedure through the 30 day follow up period

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

Time frame: Intra-procedure through the 30 day follow up period

Data from ClinicalTrials.gov

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