Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
ConditionUreter Injury
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorProve pharm
About this trial
This is an open label, randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Indigotindisulfonate Sodium Injection, USP 0.8% when used as an aid in the determination of ureteral patency in patients with different degrees of renal impairment.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Saline Injection 0.9%
- Indigotindisulfonate sodium 0.8%
Treatment groups
48 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov