Back to resultsTechnique for Localization of Pulmonary Nodules Using Spy Thoracoscope System
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
ICG Localization with Spy thoracoscope localization
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
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.
Sites / Locations
- University Health Network: Toronto General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VATS wedge lung resection
Arm Description
Outcomes
Primary Outcome 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02090660
First Posted
March 10, 2014
Last Updated
February 22, 2018
Sponsor
University Health Network, Toronto
Collaborators
Novadaq Technologies ULC, now a part of Stryker
1. Study Identification
Unique Protocol Identification Number
NCT02090660
Brief Title
Technique for Localization of Pulmonary Nodules Using Spy Thoracoscope System
Official Title
Feasibility of a Novel Minimally Invasive Technique for Localization of Pulmonary Nodules Using the Spy Thoracoscope System
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Novadaq Technologies ULC, now a part of Stryker
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VATS wedge lung resection
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
ICG Localization with Spy thoracoscope localization
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuhiro Yasufuku, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network: Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Technique for Localization of Pulmonary Nodules Using Spy Thoracoscope System
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