Back to resultsCarpal Tunnel Release Effects on Median Nerve Perfusion
Primary Purpose
Carpal Tunnel Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indigocyanine green dye
Sponsored by
About this trial
This is an interventional other trial for Carpal Tunnel Syndrome
Eligibility Criteria
Inclusion Criteria:
- carpal tunnel syndrome
- 18 years or older
Exclusion Criteria:
- pregnant
- less than 18 years of age
- allergy to iodide or iodinated contrast agents
Sites / Locations
- Henry Ford Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Median nerve perfusion
Arm Description
Injection of indigocyanine green dye to evaluate perfusion of the median nerve with the SPY scope before and after carpal tunnel release
Outcomes
Primary Outcome Measures
Effect of median nerve perfusion with carpal tunnel release
This study aims to examine the effect of carpal tunnel release on blood flow to the median nerve using SPY scope imaging.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01610739
Brief Title
Carpal Tunnel Release Effects on Median Nerve Perfusion
Official Title
Effect of Carpal Tunnel Release on Median Nerve Perfusion Using SPY Scope Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
never initiated; did not recruit patients
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to examine the effect of carpal tunnel release on blood flow to the median nerve using SPY scope imaging to view the perfusion to the nerve.
Detailed Description
The study will involve patients undergoing carpal tunnel release surgery at our institution, with no change in the actual procedure performed. Using the SPY Scope, we will measure blood flow prior to the carpal tunnel release, and again measure once carpal tunnel release has been performed, in order to compare the values. This may add roughly 15 minutes to the total procedure time, however, no steps in the actual operation will be altered or affected in any way.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Median nerve perfusion
Arm Type
Other
Arm Description
Injection of indigocyanine green dye to evaluate perfusion of the median nerve with the SPY scope before and after carpal tunnel release
Intervention Type
Drug
Intervention Name(s)
Indigocyanine green dye
Other Intervention Name(s)
Indigocyanine green dye (ICG)
Intervention Description
Each patient will receive 1 injection of indigocyanine green dye using 2.5 mg/mL concentration of the imaging agent. 3mL of this mixture will be injected intravenously, followed by 10mL NS bolus, just prior to imaging with the SPY scope
Primary Outcome Measure Information:
Title
Effect of median nerve perfusion with carpal tunnel release
Description
This study aims to examine the effect of carpal tunnel release on blood flow to the median nerve using SPY scope imaging.
Time Frame
intraoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
carpal tunnel syndrome
18 years or older
Exclusion Criteria:
pregnant
less than 18 years of age
allergy to iodide or iodinated contrast agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia M Obeid, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
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Carpal Tunnel Release Effects on Median Nerve Perfusion
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