Carpal Tunnel Release Effects on Median Nerve Perfusion

Carpal Tunnel Syndrome Clinical Trial

Official title:

Effect of Carpal Tunnel Release on Median Nerve Perfusion Using SPY Scope Imaging

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01610739
• Other study ID #: HFHSobeid2012
• Status: Withdrawn
• Phase: N/A
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2019
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Drug:
• Indigocyanine green dye
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

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	intraoperatively