SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow

Cubital Tunnel Syndrome Clinical Trial

Official title:

SPY Angiography To Determine the Extent of Nerve Release After Nerve Decompression

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05332405
• Other study ID #: 21-01449
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 26, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: June 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cubital Tunnel Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	nerve function determined by grip strength	Assessed by comparing the value of grip strength at each follow-up visits to the value of grip strength before nerve release surgery	2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits
Secondary	Change in Monofilament sensory testing	Assessed by comparing the Monofilament sensory testing score at each follow-up visit to the Monofilament sensory testing score before nerve release surgery	2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits
Secondary	Change in DASH Score	DASH score at each follow-up visit does not differ from that before nerve release surgery. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. A higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on the test ranges is from 0 (no disability) to 100 (most severe disability).	2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits