Technique for Localization of Pulmonary Nodules Using Spy Thoracoscope System

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network: Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICG Localization with Spy thoracoscope localization

Other

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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

Novadaq Technologies ULC, now a part of Stryker

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2016
First posted: Mar 18, 2014
Registry last updated: Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed