Carpal Tunnel Release Effects on Median Nerve Perfusion

NCT ID: NCT01610739

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Indigocyanine green dye

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Indigocyanine green dye (ICG)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Nadia M. Obeid, MD

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nadia M Obeid, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

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Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HFHSobeid2012

Identifier Type: -

Identifier Source: org_study_id

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