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Glow-in-the-Dark dye could prevent surgical blunders

NCT ID NCT05954767

Diagnosis Sponsor: Intuitive Surgical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a dye called IS-001 that is injected into the blood to make the ureters (tubes from kidney to bladder) glow under a special camera during robotic gynecological surgery. The goal was to help surgeons see the ureters more clearly and avoid accidentally injuring them. 189 women scheduled for robotic surgery took part. The dye's effectiveness was measured by how well independent reviewers could see the ureters with the dye versus standard white light.

What this could mean

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

Active substance
IS-001 (a dye injected into the vein to make ureters glow under special light)
What this could lead to
If it works, this could help surgeons avoid accidentally injuring the ureters during gynecological surgery, making the procedure safer.
What could go wrong
This trial is already completed, but the results are not yet widely known. The dye may not improve visibility enough to change surgical outcomes, and there could be allergic reactions or other side effects.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

189 people

The number who actually took part.

Started

Jan 2024

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

16 to 75 years

Sex

Female participants only

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: 1. Female subject is between the ages of 16 and 75, inclusive at time of consent. 2. Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® Surgical System with Firefly® Fluorescence Imaging. 3. Subject and/or subject's parent/guardian is willing and able to provide informed consent and/or assent as applicable. Exclusion Criteria: 1. Subject is pregnant or nursing. 2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 3. Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months 4. Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile 5. Subject has a known or suspected hypersensitivity to indocyanine green (ICG) 6. Subject has any of the following screening laboratory values: 1. eGFR \< 60 mL/min/1.73 m\^2 2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × ULN 3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × ULN. 7. Planned use of CYTALUX™ (pafolacianine) for surgery

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Conditions

The condition(s) this trial relates to.

injury

As listed by the trial registrant

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

Ureter injury

Contacts and locations

Locations

  • E.W. Sparrow Hospital

    Lansing, Michigan, 48912, United States

  • HCA Mercy Hospital

    Miami, Florida, 33133, United States

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

  • MountainView Hospital

    Las Vegas, Nevada, 89128, United States

  • OhioHealth

    Columbus, Ohio, 43214, United States

  • Orlando Health

    Orlando, Florida, 32806, United States

  • St. David's Surgical Hospital

    Austin, Texas, 78681, United States

  • The Ohio State Unversity

    Columbus, Ohio, 43210, United States

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