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Indigotindisulfonate Sodium for Ureter Patency
Phase 4
Recruiting
Research Sponsored by Prove pharm
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects between ≥ 18 and ≤ 85 years old
Be older than 18 years old
Must not have
Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR <30 mL/min (calculated using the MDRD formula and standardized by using individual's body surface area) or need for dialysis in the near future, or having only 1 kidney
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post study drug administration
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial tests a drug to see if it helps determine the patency of a ureter during surgical procedures. Participants ages 18-85 will be screened and randomized to receive either a high or low dose of the drug. Safety assessments will be done during and after the procedure.
Who is the study for?
Adults aged 18-85 needing ureter patency assessment during surgery can join. Excluded are those with severe kidney failure, major systemic diseases, expected non-compliance, life expectancy under 6 months, pregnancy, breastfeeding, dye allergies or substance abuse within the last 6 months.
What is being tested?
The trial tests two doses of Bludigo™ (2.5 mL and 5.0 mL) against saline to check for ureter blockages during surgery. Participants serve as their own controls by getting saline before Bludigo™ and are randomly assigned to a dose level based on BMI.
What are the potential side effects?
Possible side effects include allergic reactions to the dye in Bludigo™ which may manifest as skin rashes or more severe responses if one has a history of sensitivity to dyes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 85 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have advanced kidney failure or only one kidney.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days post study drug administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post study drug administration
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Paired sample difference (Bludigo™-Saline) in urine jet conspicuity score .
Responders to Bludigo
Secondary study objectives
Changes in ECG post treatment
Changes in blood pressure by dose group and BMI (kg/m^2)
Changes in clinical safety laboratory values
+6 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low DoseExperimental Treatment2 Interventions
58 subjects randomly treated with 2.5 mL of drug
Group II: High DoseExperimental Treatment2 Interventions
58 subjects randomly treated with 5 mL of drug
Group III: SalinePlacebo Group1 Intervention
116 subjects treated with 5 ml of saline then crossover to treatment arm
Find a Location
Who is running the clinical trial?
Prove pharmLead Sponsor
4 Previous Clinical Trials
211 Total Patients Enrolled
3 Trials studying Ureter Injury
187 Patients Enrolled for Ureter Injury