SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow

NCT ID: NCT05332405

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-26
• Study Completion Date: 2024-04-01

Brief 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.

Detailed Description

The purpose of this study is to use laser imaging to determine the extent of nerve decompression (release) while patients are still in surgery. Commonly, this is determined by electrodiagnostic tests or physical examination. The researchers will use the SPY elite device along with an injection of a drug called SPY Agent green (indocyanine green) in an imaging procedure called fluorescence angiography to visualize the change in blood supply to the nerve, following the nerve decompression surgery and assess if SPY is a useful tool for evaluating the success of nerve decompression surgery. The use of fluorescence angiography with the SPY elite device and SPY agent green is Food and Drug Administration (FDA) approved.

Conditions

Cubital Tunnel Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Group

Participants will have planned surgical procedure to repair the median or ulnar nerve compression. During the procedure, the doctor will administer a small injection of indocyanine green (ICG) and laser angiography using the SPY Elite device will be used to evaluate blood flow and extent of nerve decompression at the surgical site. Participation will also involve filling out two questionnaires on pain and function level and an examination of hand strength and range of motion.

Group Type: EXPERIMENTAL

Indocyanine green

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

SPY AGENT GREEN

Eligibility Criteria

Inclusion Criteria

• 18 years old or older; male and female patients
• Ulnar Nerve Compression at the Elbow
• Failed conservative treatment (i.e. hand therapy, pain medications, splinting)
• Able to provide informed consent

Exclusion Criteria

• Pregnancy/breastfeeding
• Thyroid Disease
• Vascular Disease
• Known allergy to any study drug

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Hacquebord, MD

Role: STUDY_DIRECTOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

21-01449

Identifier Type: -

Identifier Source: org_study_id