Blue dye could help surgeons spot blocked ureters during operations
NCT ID NCT06085183
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a blue dye called Bludigo to help surgeons see if the tubes from the kidneys to the bladder (ureters) are open during surgery. About 48 adults with different levels of kidney function will receive either the dye or a saltwater placebo. The goal is to see if the dye makes the urine flow easier to see, especially in patients with kidney problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Indigotindisulfonate sodium (Bludigo)
- What this could lead to
- If successful, this could give surgeons a reliable way to check if the ureters are open during surgery, even in patients with kidney problems.
- What could go wrong
- This is a small, early-phase study with only 48 participants, so results may not apply to everyone. The dye may not work as well in people with severe kidney impairment.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Subjects between ≥ 18 and ≤ 85 years old * Subjects who signed a written IRB approved, informed consent form * Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure. * An estimated glomerular filtration rate (eGFR) at baseline will be determined using the Modification of Diet in Renal Disease formula (MDRD) and standardized by using individual's body surface area. Subject's renal function will be defined based on the following criteria: * Normal subjects: eGFR of ≥90 mL/min * Mild renal impairment: eGFR 60 to 89 mL/min * Moderate renal impairment: eGFR 30 to 59 mL/min * Severe renal impairment: eGFR 15 to 29 mL/min Subjects with normal renal function that are judged to be in good health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the Screening Visit and/or prior to administration of study drug. Patients with renal impairment (mild, moderate, or severe) who have a diagnosis of chronic (\>6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in renal function) renal insufficiency meeting criteria at the Screening Visit Exclusion Criteria: * Subjects with eGFR \<15 mL/min or expected need for dialysis in the near future, or having only 1 kidney * Subjects with known severe hypersensitivity reactions to Bludigo™ or other dyes, including contrast dyes * Known history of drug or alcohol abuse within 6 months prior to the time of screening visit * Subjects, as assessed by the Investigator, with conditions/concomitant diseases precluding their safe participation in this study (e.g., major systemic diseases) * Unable to meet specific protocol requirements (e.g., scheduled visits) or subject is uncooperative or has a condition that could lead to non-compliance with the study procedures * Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol * Subjects with life expectancy \< 6 months * Requirement for concomitant treatment that could bias primary evaluation. * Subjects who are pregnant or breast-feeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Albany Medical Center
RECRUITINGAlbany, New York, 12008, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Glow-in-the-Dark dye could prevent surgical blunders
- Blue dye could make Children's surgery safer
- Blue dye could make surgery safer by spotting hidden ureter injuries
- Glow-in-the-dark dye could save kidneys during surgery