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Carpal Tunnel Release Effects on Median Nerve Perfusion

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Nadia M. Obeid, MD, Henry Ford Health System.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01610739
First Posted: June 4, 2012
Last Update Posted: July 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nadia M. Obeid, MD, Henry Ford Health System
  Purpose
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.

Condition Intervention
Carpal Tunnel Syndrome Drug: Indigocyanine green dye

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effect of Carpal Tunnel Release on Median Nerve Perfusion Using SPY Scope Imaging

Resource links provided by NLM:


Further study details as provided by Nadia M. Obeid, MD, Henry Ford Health System:

Primary Outcome Measures:
  • Effect of median nerve perfusion with carpal tunnel release [ Time Frame: intraoperatively ]
    This study aims to examine the effect of carpal tunnel release on blood flow to the median nerve using SPY scope imaging.


Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Median nerve perfusion
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
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
Other Name: Indigocyanine green dye (ICG)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610739


Contacts
Contact: Nadia M Obeid, M.D. 2487090067 nobeid1@hfhs.org
Contact: Kenneth Moquin, M.D. 3139162676 kmoquin1@hfhs.org

Locations
United States, Michigan
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Nadia M Obeid, M.D.         
Sub-Investigator: Kenneth Moquin, M.D.         
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Nadia M Obeid, MD Henry Ford Health System
  More Information

Responsible Party: Nadia M. Obeid, MD, M.D., Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01610739     History of Changes
Other Study ID Numbers: HFHSobeid2012
First Submitted: May 31, 2012
First Posted: June 4, 2012
Last Update Posted: July 19, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries