search
Back to results

SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow

Primary Purpose

Cubital Tunnel Syndrome

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Indocyanine green
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cubital Tunnel Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Group

Arm 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.

Outcomes

Primary Outcome Measures

Change in level of Fluorescence before and after nerve release.
Assessed by comparing the SPY angiography value before and after nerve release surgery

Secondary Outcome Measures

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
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
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).

Full Information

First Posted
April 11, 2022
Last Updated
June 27, 2023
Sponsor
NYU Langone Health
search

1. Study Identification

Unique Protocol Identification Number
NCT05332405
Brief Title
SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow
Official Title
SPY Angiography To Determine the Extent of Nerve Release After Nerve Decompression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Obsolete study
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cubital Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Indocyanine green
Other Intervention Name(s)
SPY AGENT GREEN
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in level of Fluorescence before and after nerve release.
Description
Assessed by comparing the SPY angiography value before and after nerve release surgery
Time Frame
2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits
Secondary Outcome Measure Information:
Title
nerve function determined by grip strength
Description
Assessed by comparing the value of grip strength at each follow-up visits to the value of grip strength before nerve release surgery
Time Frame
2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits
Title
Change in Monofilament sensory testing
Description
Assessed by comparing the Monofilament sensory testing score at each follow-up visit to the Monofilament sensory testing score before nerve release surgery
Time Frame
2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits
Title
Change in DASH Score
Description
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).
Time Frame
2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Hacquebord, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Study Director
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will only be used for this study

Learn more about this trial

SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow

We'll reach out to this number within 24 hrs