Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency
Status:
Recruiting
Trial end date:
2025-01-30
Target enrollment:
Participant gender:
Summary
This is a randomized, multicenter study to evaluate the efficacy and safety of two dose
levels (2.5 mL and 5.0 mL) of Bludigo™ (indigotindisulfonate Sodium Injection, USP) 0.8% when
used as an aid in the determination of ureteral patency.
Subjects scheduled for a surgical procedure in which the patency of the ureter must be
assessed by cystoscopy following the procedure, age 18 to 85 years inclusive, will be
screened for participation. Screening will occur within 30 days before study drug
administration (Day of Surgery). After signing the informed consent, review of inclusion and
exclusion criteria will be performed, the collection of concomitant medications, medical
history, physical examination, baseline laboratory testing, 12-lead ECG, and vital sign
measurements will be completed during the screening visit.
On the day of surgery (Day 1) subjects will be evaluated for eligibility for randomization.
Eligible subjects will be stratified by BMI (<30.0 kg/m2or ≥ 30.0 kg/m2) and randomized in a
1:1 ratio to receive a dose of either Bludigo™ high dose (5.0 mL) or Bludigo™ low dose (2.5
mL). Each randomized subject will serve as his/her own control (i.e., intra-patient
controlled) by receiving a dose of normal saline prior to receiving the randomized Bludigo™
dose.
All treated subjects will have a follow-up visit 7 to 30 days (± 2 days) after the procedure.
A final telephone follow-up call will occur on Day 30 (± 2 days) in subjects who have the
follow-up visit before Day 28. Safety assessments will include monitoring of AEs during and
post the procedure, clinical laboratory tests, 12-Lead ECG, and vital sign measurements.