SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow

NCT05332405 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 21-01449
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cubital Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in level of Fluorescence before and after nerve release.

  Assessed by comparing the SPY angiography value before and after nerve release surgery

  2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits

Secondary Outcomes (3)

• nerve function determined by grip strength

  2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits

• Change in Monofilament sensory testing

  2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits

• Change in DASH Score

  2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits

Study Arms (1)

Study Group

EXPERIMENTAL

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.

Drug: Indocyanine green

Interventions

Indocyanine green 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.

Also known as: SPY AGENT GREEN

Study Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Ulnar Neuropathies; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Ulnar Nerve Compression Syndromes; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jacques Hacquebord, MD

  NYU Langone Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 18, 2022
• Study Start: May 26, 2022
• Primary Completion: October 1, 2023
• Study Completion: April 1, 2024
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)