Glowing dye helps surgeons avoid a rare but serious injury
NCT ID NCT05754333
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new dye called ASP5354 that makes the ureter (the tube from kidney to bladder) glow under a special camera during abdominal surgery. The goal was to help surgeons see the ureter more clearly and avoid accidentally injuring it. About 107 people aged 12 and older took part. The dye was injected at the start of surgery, and images were compared between normal light and the special glowing mode.
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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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107 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Jan 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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12 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(s) 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 eGFR using the modification of diet in renal disease (MDRD) formula for adults or the Schwartz formula for adolescents at the screening visit. * Adult normal/mild eGFR cohort: eGFR ≥ 60 mL/min * Adult moderate/severe eGFR cohort: eGFR ≥ 15 to \< 60 mL/min * Adolescent cohort: eGFR ≥ 60 mL/min * Female participant is not pregnant and at least 1 of the following conditions apply: * Not a woman of childbearing potential (WOCBP). * WOCBP 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 (and/or participant's parent or legal guardian) agrees not to participate in another interventional study involving unapproved study medication 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 that would impact safety or study compliance. * Participant has any clinically relevant laboratory abnormality that could contraindicate surgery. * Participant with body weight \< 30 kilogram (kg). * 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 near-infrared fluorescent (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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Advent Health Tampa
Tampa, Florida, 33613, United States
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AdventHealth Orlando
Orlando, Florida, 32803, United States
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
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Cleveland Clinic Florida
Weston, Florida, 33331, United States
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
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