Carpal Tunnel Release Effects on Median Nerve Perfusion

NCT01610739 | Withdrawn

• 1 other identifier: HFHSobeid2012
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Median nerve perfusion

OTHER

Injection of indigocyanine green dye to evaluate perfusion of the median nerve with the SPY scope before and after carpal tunnel release

Drug: Indigocyanine green dye

Interventions

Indigocyanine green dye DRUG

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

Also known as: Indigocyanine green dye (ICG)

Median nerve perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• carpal tunnel syndrome
• years or older

You may not qualify if:

• pregnant
• less than 18 years of age
• allergy to iodide or iodinated contrast agents

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Nadia M Obeid, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 4, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

US (1)