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NCT02090660 Clinical Trial

Technique for Localization of Pulmonary Nodules Using Spy Thoracoscope System

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02090660
Other study ID # 12-5454
Secondary ID
Status Completed
Phase Phase 2
First received March 10, 2014
Last updated February 22, 2018
Start date April 2014

Study information
Verified date February 2018
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• ICG Localization with Spy thoracoscope localization

Locations
Country Name City State
Canada University Health Network: Toronto General Hospital Toronto Ontario

Sponsors (2)
Lead Sponsor Collaborator
University Health Network, Toronto Novadaq Technologies Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compare incidence of Adverse Events (AE) occurrence due to ICG injection with micro-coil placement versus overall AE occurrence for micro-coil placement alone. Within 4 hours of ICG injection
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