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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 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.

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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.

Conditions Studied

Interventions

  • DRUG Indocyanine Green

Study Locations (1)

New York

  • NYU Langone Health - New York

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2021-01-27
Est. Completion 2025-09-01
Phase Phase 1

Sponsor

NYU Langone Health

1,164 total trials

What the Registry Record Tells You About NCT04340752

The ClinicalTrials.gov registry entry for NCT04340752 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,280-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (98% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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