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NCT04340752 · ClinicalTrials.gov registry record · Phase 1
Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy
A Phase 1 study of Rotator Cuff Tears, sponsored by NYU Langone Health.
- Active
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04340752: Active Phase 1 study of Rotator Cuff Tears, sponsored by NYU Langone Health.
NCT04340752 is a Phase 1 study of Rotator Cuff Tears that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 20 participants, below the 1,280-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04340752, a Phase 1 study of Rotator Cuff Tears, is active but no longer recruiting, sponsored by NYU Langone Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Advanced Imaging Modality (AIM) arthroscopy videos for each dosing arm will be collected and five signal intensity readings will be collected from the rotator cuff within each video. The ability to visualize rotator cuff vascularity will be graded by surgeons blinded to the ICG dosing using a 5 point Likert scale where 1 indicates worst visibility and 5 indicates best visibility. Post-hoc ANOVA analysis of surgeons' responses to determine what dose of ICG is optimal for the surgery.
Conditions Studied
Interventions
- DRUG Indocyanine Green
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-01-27 |
| Est. Completion | 2025-09-01 |
| Phase | Phase 1 |
What the registry record for NCT04340752 still lists
NCT04340752 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,280-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Rotator Cuff Tears appearing as the primary indexed condition, and to 1 intervention - of which Indocyanine Green is the first listed.
NCT04340752 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04340752 about?
NCT04340752 is a clinical study titled "Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy". 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 a...
What is the current status of trial NCT04340752?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2021-01-27. Estimated completion is 2025-09-01.
What conditions does trial NCT04340752 study?
This clinical trial studies the following conditions: Rotator Cuff Tears.
What interventions are being tested in trial NCT04340752?
The interventions under investigation include: Indocyanine Green (DRUG).
Who is sponsoring clinical trial NCT04340752?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04340752 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04340752's enrollment target sits among peer trials
20 20th of 20 the lowest of 20 other Rotator Cuff Tears trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rotator Cuff Tears trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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