← Back to Search

Diagnostic Agent

Indocyanine Green Imaging for Rotator Cuff Surgery

Phase 1

Recruiting

Led By Kirk Campbell

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients has full or partial thickness rotator cuff tear and is scheduled to undergo arthroscopic rotator cuff repair

Patient is at least 18 years of age and less than 80 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months post operative visit

Awards & highlights

Study Summary

This trial is looking at whether or not a certain dye can help predict which patients are more likely to experience a re-tear of their rotator cuff after surgery.

Who is the study for?

This trial is for adults between 18 and 79 years old who are scheduled for arthroscopic repair of full or partial thickness rotator cuff tears. It's not suitable for pregnant individuals, those with recent iodide-based radiology studies, or anyone allergic to iodides.Check my eligibility

What is being tested?

The study tests the optimal dosing of Indocyanine Green (ICG), a dye used in surgery to visualize blood vessels in the rotator cuff during arthroscopy, aiming to predict the success of surgical repairs.See study design

What are the potential side effects?

While ICG is generally safe, potential side effects may include allergic reactions related to iodine sensitivity. However, specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a torn rotator cuff and will have surgery to fix it.

Select...

I am between 18 and 79 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months post operative visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months post operative visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months post operative visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Optimal dosing of an intravenous fluorescence solution (ICG) for arthroscopic evaluation of rotator cuff vascularity

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 3: ICG 25 mgExperimental Treatment1 Intervention

Subjects in this group are randomized to receive 25 mg dose of Indocyanine Green (ICG) intravenously during the clinical surgery. ICG is a substance that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision.

Group II: Group 2:ICG 12.5 mgExperimental Treatment1 Intervention

Subjects in this group are randomized to receive 12.5 mg dose of Indocyanine Green (ICG) intravenously during the clinical surgery. ICG is a substance that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision.

Group III: Group 1:ICG 7.5 mgExperimental Treatment1 Intervention

Subjects in this group are randomized to receive 7.5 mg dose of Indocyanine Green (ICG) intravenously during the clinical surgery. ICG is a substance that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Indocyanine Green

2008

Completed Phase 2

~1050

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

840,537 Total Patients Enrolled

Kirk CampbellPrincipal InvestigatorNYU Langone Health

1 Previous Clinical Trials

80 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals are presently involved in the ongoing clinical trial?

"Affirmative. According to information on clinicaltrials.gov, this research study is actively seeking applicants that meet the criteria. The original post date was January 27th 2021 and the data has recently been updated as of October 14th 2022. This trial requires 30 patients at one particular site in order to continue."

Answered by AI

Is there any possibility for me to join this research initiative?

"To be accepted into this medical trial, prospective participants must have a rotator cuff tear and fall in the age range of 18 to 80 years old. The total number of enrollees is projected at 30."

Answered by AI

Does this research endeavor admit individuals aged over forty?

"This trial is accessible to individuals over 18 years of age and less than 80 years old."

Answered by AI

Is this research currently recruiting participants?

"That is correct. Clinicaltrials.gov illustrates that this medical trial, which was first shared on January 27th 2021, remains open for enrolment and requires 30 patients from a single site to complete the study."

Answered by AI

Has the FDA authorized Group 2:ICG 12.5 mg for public consumption?

"Our team has evaluated Group 2:ICG 12.5 mg and, owing to the Phase 1 trial status of this drug, assigned it a safety rating of 1 out of 3 based on limited evidence concerning efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy

2021. "Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04340752.