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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Ion Endoluminal System

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.

• Study Type: Observational
• Enrollment (Actual): 288

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who underwent an Ion Endoluminal dye marking procedure with a pulmonary nodule, 18 years or older, who subsequently underwent a resection of their pulmonary nodule.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with Ion Endoluminal dye marking of pulmonary nodule for resection; Subjects in which a pulmonary lesion dye marking procedure was attempted or performed with the Ion Endoluminal System in anticipation of resection of the lesion	Device: Ion Endoluminal System; Ion Endoluminal dye marking procedure for pulmonary nodule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pneumothorax	Incidence of all pneumothoraces related to the Ion procedure	Intra-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	All adverse events related to the Ion procedure	Intra-procedure until the start of the resection procedure
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
Operative time	Time from start of resection procedure to end of resection procedure (skin-to-skin time)	Intra-operative
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
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

Collaborators and Investigators

• Sponsor: Intuitive Surgical

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ISI-ION-R02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes