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SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow

NCT05332405 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-06-29

No results posted yet for this study

Summary

Patients with vascular disease, thyroid disease or an allergy to indocyanine green (ICG) will be excluded. Patients with either median or ulnar nerve compression will be treated with nerve decompression. SPY angiography will be used to assess the vascularity of the nerve both pre and post release as the primary outcome measure.

Conditions

  • Cubital Tunnel Syndrome

Interventions

DRUG

Indocyanine green

The subject will receive 3mL of ICG followed by 10 mL of sterile saline intravenously as per the Spy Elite protocol. Within minutes of the injection, the SPY machine will be turned on and focused on the nerve. The SPY machine gives a digital read out of the % fluorescence when the dye reaches the nerve. This number correlates with blood flow or vascularity.

Sponsors & Collaborators

Principal Investigators

  • Jacques Hacquebord, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-26
Primary Completion
2023-10-01
Completion
2024-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05332405 on ClinicalTrials.gov