SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow

NYU Langone Health

Status and phase: Withdrawn; Phase 4

Conditions: Cubital Tunnel Syndrome

Treatments: Drug: Indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT05332405

21-01449

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Study Group

Experimental group

Description:

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.

Treatment:

Drug: Indocyanine green