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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post study drug administration

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

I am between 18 and 85 years old.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post study drug administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Paired sample difference (Bludigo™-Saline) in urine jet conspicuity score .

Responders to Bludigo

Secondary outcome measures

Changes in ECG post treatment

Changes in blood pressure by dose group and BMI (kg/m^2)

Changes in clinical safety laboratory values

+6 more

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Prove pharmLead Sponsor

3 Previous Clinical Trials

193 Total Patients Enrolled

2 Trials studying Ureter Injury

169 Patients Enrolled for Ureter Injury

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age cap for the participants of this medical experiment?

"The minimum entry age for this clinical trial is 18 while the maximum stands at 85, as set out in the inclusion criteria."

Answered by AI

Who is eligible to partake in this experiment?

"The requirements to partake in this clinical trial comprise a diagnosis of ureter injury and being aged between 18-85. This study needs 116 participants overall."

Answered by AI

Has the Federal Drug Administration authorized High Dose for medical use?

"Data suggests that High Dose is a safe treatment, so it was given a score of 3. This conclusion was drawn because this Phase 4 trial has been approved by the relevant governing bodies."

Answered by AI

Are there any remaining vacancies for participants in this research program?

"Affirmative. The information published on clinicaltrials.gov states that this trial is currently seeking out individuals to join the study, which was first posted online on October 12th 2023 and edited more recently on October 17th 2023. There are 116 positions available at a single site for enrolment into the research project."

Answered by AI

What is the aggregate size of participants in this research project?

"Verified. According to the information published on clinicaltrials.gov, this medical trial is currently recruiting and opened for applications since October 12th 2023; a recent update was performed on October 17th of same year. 116 patients are required at one single location for this study."

Answered by AI

What goals is this trial aiming to accomplish?

"Per Prove pharm, the primary outcome of this study is Responders to Bludigo. Additionally, secondary evaluations will be conducted that examine Changes in vital signs post treatment (clinically important changes), Incidence of adverse events and serious adverse events (percentage within each group) and Changes in clinical safety laboratory values (again clinically important shifts). All these measurements occur after a 10 minute administration period."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency

2023. "Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06054880.