Status:
ACTIVE_NOT_RECRUITING
Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy
Lead Sponsor:
NYU Langone Health
Conditions:
Rotator Cuff Tears
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 measu...
Detailed Description
The primary study objective is to determine optimal dosing of an intravenous fluorescence solution (IC-Green) for arthroscopic evaluation of rotator cuff vascularity. The primary endpoint is surgeon's...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04340752
Start Date
January 27 2021
End Date
September 1 2025
Last Update
August 1 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016