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Dye test could help surgeons spot shoulder Re-Tear risk during surgery

NCT ID NCT04340752

Knowledge-focused Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial tests different doses of a fluorescent dye called IC-Green in people having arthroscopic rotator cuff repair. The dye binds to blood proteins and makes blood vessels visible under a special camera. The goal is to find the best dose for seeing blood flow in the torn tendon during surgery. Better visibility of blood flow might one day help surgeons predict and prevent re-tears, but this study only focuses on finding the right dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Indocyanine Green (ICG) dye
What this could lead to
If successful, this could help surgeons see blood flow in the shoulder during rotator cuff repair, potentially predicting and preventing re-tears.
What could go wrong
This is a very early, small study focused only on finding the best dye dose. It does not test whether seeing blood flow actually prevents re-tears, so the real benefit remains unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

Jan 2021

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rotator cuff tears

Contacts and locations

Locations

  • NYU Langone Health

    New York, New York, 10016, United States

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