NCT05546437

A Multicenter Retrospective Review to Evaluate the Feasibility of Dye Marking Using the Ion Endoluminal System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 288 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this study is to assess the ability of the Ion Endoluminal System to perform pleural based tissue dye marking in anticipation of a lung resection.

Detailed description

This study is a retrospective multicenter chart review of patients who underwent a pleural based tissue dye marking with the Ion Endoluminal System in anticipation of lung resection. The aim of the study is to assess the feasibility of the Ion Endoluminal System to perform pleural based tissue marking. As this is a retrospective study, the Ion dye marking procedure will have been performed according to the physician's standard technique. All consecutive cases in which a dye marking procedure was attempted and/or completed with the Ion Endoluminal System will be included.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	Ion Endoluminal System	Ion Endoluminal dye marking procedure for pulmonary nodule

Timeline

• Start date: 2022-07-22
• Primary completion: 2023-04-30
• Completion: 2023-12-31
• First posted: 2022-09-19
• Last updated: 2024-03-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study