Feasibility of a Novel Minimally Invasive Technique for Localization of Pulmonary Nodules Using the Spy Thoracoscope System

University Health Network, Toronto1 site in 1 country20 target enrollmentApril 2014

ConditionsLung Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Lung Cancer
Sponsor: University Health Network, Toronto
Enrollment: 20
Locations: 1
Primary Endpoint: Compare incidence of Adverse Events (AE) occurrence due to ICG injection with micro-coil placement versus overall AE occurrence for micro-coil placement alone.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will determine the feasibility of the novel Indocyanine Green (ICG) fluorescence localization technique with a Laser fluorescence thoracoscope system.

The primary objective of this study is to prove the validity and safety of our novel fluorescent localization method with utilized ICG and novel near infra-red fluorescence videoscope system.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

February 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Health Network, Toronto

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Any patient scheduled for a VATS wedge lung resection using CT guided micro-coil lung implantation for the localization of the lung lesion.

Exclusion Criteria

•Any patients with an allergy to iodine, shellfish, or cough mixture, betadine or other iodine contrast agents.
•Pregnant or potentially pregnant women.

Outcomes

Primary Outcomes

Compare incidence of Adverse Events (AE) occurrence due to ICG injection with micro-coil placement versus overall AE occurrence for micro-coil placement alone.

Time Frame: Within 4 hours of ICG injection