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Indocyanine green for Cubital Tunnel Syndrome

Phase 4
Waitlist Available
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits
Awards & highlights

Study Summary

This trial is testing a new way to treat patients with median or ulnar nerve compression by using SPY angiography to assess the vascularity of the nerve.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in level of Fluorescence before and after nerve release.
Secondary outcome measures
Change in DASH Score
Change in Monofilament sensory testing
nerve function determined by grip strength

Side effects data

From 2015 Phase 2 trial • 30 Patients • NCT01662752
97%
Wound pain
40%
Nausea
13%
Ileus
10%
Vomiting
7%
Bloating
7%
Urinary tract infection
3%
Atrial fibrillation
3%
Dizziness
3%
Palpitations
3%
Paroxysmal atrial fibrillation
3%
Constipations
3%
Distended abdomen
3%
Epigastric pain
3%
Hiccough
3%
Febrile reaction
3%
Rigors
3%
Postoperative ileus
3%
Low haemoglobin
3%
Groin pain
3%
Tremor
3%
Confusion
3%
Urinary retention
3%
Atelectasis
3%
Low blood pressure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Indocyanine Green

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study GroupExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Indocyanine green
FDA approved

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,726 Total Patients Enrolled
1 Trials studying Cubital Tunnel Syndrome
2 Patients Enrolled for Cubital Tunnel Syndrome
Jacques Hacquebord, MDStudy DirectorNYU Langone Health
1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for participants to join this research effort?

"Confirming clinicaltrials.gov, this experiment is presently seeking enrollees with the protocol having been published on May 26th 2022 and amended most recently on August 9th 2022."

Answered by AI

Has Indocyanine green received approval from the Food and Drug Administration?

"There is a substantial body of evidence demonstrating Indocyanine green's safety, leading to it receiving the maximum score of 3."

Answered by AI

How many individuals are being recruited for this research endeavor?

"Affirmative. Records on clinicaltrials.gov specify that enrollment for this study, which was first posted May 26th 2022, is still in progress. A total of 15 patients are sought from 1 medical centre."

Answered by AI

What prerequisites must a person meet in order to become involved in this research endeavor?

"This research endeavour requires a total of 15 individuals, aged between 18 and 90, to be recruited who have been diagnosed with cubital tunnel syndrome. Volunteers must meet the following criteria: Be able to provide informed consent; over 18 years old; gender does not matter; show evidence of ulnar nerve compression at their elbow joint; conservative treatments such as hand therapy or pain medications have already proven ineffective."

Answered by AI

Is this trial open to individuals who are younger than 75 years old?

"This clinical trial is open to participants between 18 and 90 years of age, as dictated by the eligibility requirements."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow
2022. "SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05332405.
~0 spots leftby Apr 2025
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