Technique for Localization of Pulmonary Nodules Using Spy Thoracoscope System

Overview

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.

Full Title of Study: “Feasibility of a Novel Minimally Invasive Technique for Localization of Pulmonary Nodules Using the Spy Thoracoscope System”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2016

Interventions

  • Other: ICG Localization with Spy thoracoscope localization

Arms, Groups and Cohorts

  • Experimental: VATS wedge lung resection

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Collaborator
    • Novadaq Technologies ULC, now a part of Stryker
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kazuhiro Yasufuku, MD, Principal Investigator, University Health Network, Toronto

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