CompletedPhase 1

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

United States20 participantsStarted 2021-01-27

Plain-language summary

Rotator cuff re-tear is a common delayed complication of arthroscopic rotator cuff repair. This process of re-tear is multifactorial and there has not been any readily identifiable perioperative measure that is predictive of subsequent rotator cuff failure. There have been no human studies looking at intraoperative assessment of rotator cuff vascularity, nor the predictive value that vascularity may have for rotator cuff re-tear. Indocyanine Green (ICG) has been safely used in patients for visualization purposes and has real potential for identifying vascularity in arthroscopic surgical patients. The aim of this study is to establish a standard dosing protocol for ICG in the arthroscopic visualization of rotator cuff vascularity.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Patient is less than 18 years of age or greater than 79 years of age * Patient has a documented allergy to iodides * Patients who have had iodide based radiology studies within the last seven (7) days prior to surgery * Patient is pregnant

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: up to 6 months post operative visit

Trial details

NCT IDNCT04340752

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

View on ClinicalTrials.gov More Rotator Cuff Tears trials