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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05546437
• Other study ID #: ISI-ION-R02
• Status: Completed
• Start date: July 22, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: December 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is 18 years or older at the time of the procedure.
• Dye marking attempted/performed using the Ion Endoluminal Platform

Exclusion Criteria:

• Resection not performed following dye marking procedure

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• Ion Endoluminal System
Ion Endoluminal dye marking procedure for pulmonary nodule

Locations

Country	Name	City	State
United States	Orlando Health	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful dye injection	The ability of the investigator to localize the marked lesion during resection, assessed by successful injection of dye, localization of due within the targeted area, and the ability to visualize the dye marking intra-operatively or on resected sample	Intra-procedure through the release of the final pathology report, approximately 3 days post-procedure
Primary	Pneumothorax	Incidence of all pneumothoraces related to the Ion procedure	Intra-procedure
Secondary	Adverse events	All adverse events related to the Ion procedure	Intra-procedure until the start of the resection procedure
Secondary	Procedure time	Time from start of Ion dye marking procedure (defined as when the Ion catheter crosses the endotracheal tube [ETT]) to end of Ion dye marking procedure (defined as when the Ion catheter leaves the ETT).	Intra-procedure
Secondary	Operative time	Time from start of resection procedure to end of resection procedure (skin-to-skin time)	Intra-operative
Secondary	Type of resection planned and performed	The type of resection procedure planned (ex., lobectomy, wedge resection) and whether that plan was altered after the dye marking procedure or resection has started.	Intra-operative
Secondary	Conversion to alternate approach or termination of procedure due to localization issues	Rate of resections converted to an alternative approach or terminated. Conversion is defined as a change in the procedural approach (either a different technology [ex., open resection] after the resection procedure has started. Termination is defined as prematurely ending the operation before the resection has been performed.	Intra-operative