drugset / Trial / NCT04340752

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

NCT04340752

Phase 1 Completed 20 enrolled NYU Langone Health
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2021-01-27
Primary completion
2025-09-01
Completion
2025-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Indocyanine Green Diagnostic / imaging agent 7.5 mg Intravenous
Subject Indocyanine Green Diagnostic / imaging agent 12.5 mg Intravenous
Subject Indocyanine Green Diagnostic / imaging agent 25 mg Intravenous

Indications