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

NCT05546437 | Completed FDA Device

• 1 other identifier: ISI-ION-R02
• Study Type: observational
• Target: 288
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Adverse events

  Intra-procedure until the start of the resection procedure

• Procedure time

  Intra-procedure

• Operative time

  Intra-operative

• Type of resection planned and performed

  Intra-operative

• Conversion to alternate approach or termination of procedure due to localization issues

  Intra-operative

Study Arms (1)

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

Interventions

Ion Endoluminal System DEVICE

Ion Endoluminal dye marking procedure for pulmonary nodule

Subjects with Ion Endoluminal dye marking of pulmonary nodule for resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Resection not performed following dye marking procedure

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (1)

Orlando Health

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: July 22, 2022
• Primary Completion: April 30, 2023
• Study Completion: December 31, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)