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ACTIVE NOT RECRUITING
NCT04340752
PHASE1

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

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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.

Official title: Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy: A Prospective, Randomized Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2021-01-27

Completion Date

2025-09-01

Last Updated

2025-08-01

Healthy Volunteers

No

Interventions

DRUG

Indocyanine Green

ICG is an injectable fluorescent pigment that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision. The ICG will not affect the course of the operative or postoperative period, and will be injected intravenously prior to the actual repair

Locations (1)

NYU Langone Health

New York, New York, United States