NCT02090660CompletedPhase 2
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 enrollmentStarted: April 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- 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.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
VATS wedge lung resection
Experimental
Intervention: ICG Localization with Spy thoracoscope localization (Other)
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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