A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions

Intuitive Surgical

Status: Completed

Conditions: Pulmonary Nodule; Lung Cancer

Treatments: Device: Ion Endoluminal System

Study type: Observational

Funder types: Industry

Identifiers

NCT05160571

ISI-ION-R01

Details and patient eligibility

About

This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system.

Full description

This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system. The primary objectives of the study will be performance (evaluated by diagnostic yield and sensitivity for malignancy) and safety (assessed by rate of pneumothoraces and bleeding events).

Enrollment: 279 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject was 18 years or older at the time of the procedure
• Biopsy procedure attempted/performed using the Ion Endoluminal System

Exclusion criteria

• Biopsy procedure was not attempted with the Ion Endoluminal System
• Biopsy procedure attempted with the Ion Endoluminal System occurred less than 12 months prior to IRB approval

Trial design

279 participants in 1 patient group

Subjects with Ion Endoluminal sampling of pulmonary nodule

Description:

Subjects in which a pulmonary lesion biopsy was attempted or performed with the Ion Endoluminal System

Treatment:

Device: Ion Endoluminal System