Optimizing ICG Dosing for Visualizing Rotator Cuff Blood Flow
Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy: A Prospective, Randomized Trial
This study is testing different doses of a special dye to see which one best helps doctors see blood flow in the rotator cuff during surgery, which could help reduce the chances of re-injury.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04340752 on ClinicalTrials.gov |
What this trial studies
This study aims to establish an optimal dosing protocol for Indocyanine Green (ICG) to enhance the visualization of vascularity in patients undergoing arthroscopic rotator cuff repair. By assessing the vascularity of the rotator cuff using a fluorescence solution, the study seeks to determine the effectiveness of different doses of ICG based on a surgeon's evaluation using a 5-point Likert scale. The results will be analyzed using ANOVA to compare the means of the vascularity assessments across the various doses administered. This could provide valuable insights into the relationship between vascularity and the risk of rotator cuff re-tear.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 79 who have full or partial thickness rotator cuff tears and are scheduled for arthroscopic repair.
Not a fit: Patients under 18 or over 79 years old, those with allergies to iodides, or those who have had iodide-based imaging studies recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes by identifying optimal vascular conditions that reduce the risk of rotator cuff re-tear.
How similar studies have performed: While there have been no prior human studies specifically assessing ICG for rotator cuff vascularity, the use of ICG for visualization in other surgical contexts has shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Kirk Campbell — NYU Langone Health
- Study coordinator: Michael Moore
- Email: Michael.Moore@nyulangone.org
- Phone: 3475540183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.