Clinical trial
SPY Angiography To Determine the Extent of Nerve Release After Nerve Decompression
Name
21-01449
Description
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.
Trial arms
Trial start
2022-05-26
Estimated PCD
2023-10-01
Trial end
2024-04-01
Status
Withdrawn
Phase
Early phase I
Treatment
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.
Arms:
Study Group
Other names:
SPY AGENT GREEN
Primary endpoint
Change in level of Fluorescence before and after nerve release.
2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-06-29
1 organization
1 product
1 indication
Organization
NYU Langone HealthProduct
Indocyanine greenIndication
Ulnar Tunnel Syndrome