Glow-in-the-Dark dye could prevent surgical accidents
NCT ID NCT05999747
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a dye called ASP5354 that makes the ureter glow under special cameras during abdominal surgery. The goal is to help surgeons avoid accidentally cutting or damaging the ureter, a rare but serious complication. 95 adults with normal or impaired kidney function received the dye, and surgeons compared visibility under normal light versus the glow mode. The trial is complete, and results will show if the dye improves ureter visibility.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ASP5354 (a medical dye injected into the bloodstream to highlight the ureter during surgery)
- What this could lead to
- If successful, this dye could become a standard tool to help surgeons avoid accidentally injuring the ureter during abdominal surgeries.
- What could go wrong
- This is a completed phase 3 trial with only 95 participants, so results may not apply to all patients or surgeries. The dye's effectiveness depends on the imaging equipment and surgeon skill.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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95 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Oct 2025
- 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 years and older
- 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: * Participant is scheduled to undergo minimally invasive or open abdominopelvic surgery that may require ureter identification * Participant has normal renal function or has varying degrees of chronic kidney disease as defined by the National Kidney Foundation and calculated by individual estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease formula * Adult normal/mild eGFR cohort: eGFR ≥ 60 mL/min * Adult moderate/severe eGFR cohort: eGFR ≥ 15 to \< 60 mL/min * Female participant is not pregnant and at least 1 of the following conditions apply: * Not a woman of childbearing potential * Woman of childbearing potential who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after study intervention administration. * Female participant must agree not to breastfeed starting at the administration of ASP5354 through 30 days after ASP5354 administration. * Female participant must not donate ova starting at the administration of ASP5354 through 30 days after ASP5354 administration. * Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception through at least 30 days after ASP5354 administration. * Male participant must not donate sperm starting at the administration of ASP5354 through 30 days after ASP5354 administration. * Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy from the start of ASP5354 administration through 30 days after ASP5354 administration. * Participant agrees not to participate in another interventional study involving unapproved study medications while participating in the present study. Exclusion Criteria: * Participant has any physical or psychiatric condition, which makes the participant unsuitable for study participation. * Participant is anticipated to require ureteral stenting during surgery. * Participant has an active urinary tract infection requiring antibiotic therapy. * Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III to IV) or other medical conditions would impact safety or study compliance. * Participant has any clinically relevant laboratory abnormality that could contraindicate surgery. * Participant has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used. * Participant has had previous exposure to ASP5354. * Participant has been administered ICG or other NIR-F imaging agents within 48 hours prior to ASP5354 administration, with the exception of participants who receive ICG for lymphatic mapping before the surgery. * Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to randomization. * Participant is on hemodialysis, hemodiafiltration or peritoneal dialysis.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baylor College of Medicine
Houston, Texas, 77030, United States
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Benaroya Research Institute at VA Mason
Seattle, Washington, 98101, United States
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Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
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Cleveland Clinic Florida
Weston, Florida, 33331, United States
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Duke University Hospital
Durham, North Carolina, 27705, United States
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Firsthealth of the Carolinas INC
Pinehurst, North Carolina, 28374, United States
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Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
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Houston Methodist Hospital
Houston, Texas, 77030, United States
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Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
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University of Nevada, Las Vegas
Las Vegas, Nevada, 89102, United States
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University of South Florida
Tampa, Florida, 33606, United States
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Washington University Center
St Louis, Missouri, 63110, United States
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