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Dye

Low Dose for Ureter Injury

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
Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 to 15 minutes post study drug administration
Awards & highlights

Study Summary

This trial will test the effectiveness and safety of two different doses of a medication called Indigotindisulfonate Sodium Injection in determining if the ureter (tube connecting the kidney to the bladder

Who is the study for?
This trial is for adults aged 18-85 with varying degrees of kidney function, from normal to severe impairment. They must be scheduled for surgery where ureter health will be checked and have given written consent. People with recent acute illness or unstable renal insufficiency are excluded.Check my eligibility
What is being tested?
The study tests two doses (2.5 mL and 5.0 mL) of Indigotindisulfonate Sodium Injection, USP 0.8%, to see how well it helps determine if the tubes connecting the kidneys and bladder (ureters) are open in patients with different levels of kidney function.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the dye, discomfort at injection site, changes in urine color, or other unforeseen issues related to the use of diagnostic agents in individuals with impaired kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 85 years old.
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I am scheduled for surgery that requires checking if my ureter is open using a special scope.
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My kidney function is normal, with an eGFR of 90 mL/min or higher.
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My kidney function is moderately reduced.
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My kidney function is severely reduced.
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I have long-term, stable kidney problems.
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My kidney function is slightly reduced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 to 15 minutes post study drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 to 15 minutes 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 Renal Impairment Cohort
Changes in clinical safety laboratory values
+6 more
Other outcome measures
Difference between the Bludigo™ high dose vs Bludigo™ low dose in urine jet conspicuity score
Impact of renal impairment on renal elimination of Bludigo™
Urinary excretion of Bludigo in patients with and without renal impairment

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low DoseExperimental Treatment2 Interventions
24 subjects randomly treated with 2.5 mL of drug
Group II: High DoseExperimental Treatment2 Interventions
24 subjects randomly treated with 5 mL of drug
Group III: SalinePlacebo Group1 Intervention
48 subjects treated with 5 ml of saline then crossover to treatment arm

Find a Location

Who is running the clinical trial?

Prove pharmLead Sponsor
3 Previous Clinical Trials
261 Total Patients Enrolled
2 Trials studying Ureter Injury
237 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.

Has the FDA granted approval for the use of Low Dose?

"Based on our assessment at Power, the safety rating for Low Dose is 3 since this trial falls under Phase 4, indicating regulatory approval of the treatment."

Answered by AI

Is this clinical trial open to participants who are younger than 65 years of age?

"Patients between 18 and 85 years old are eligible for participation in this research. There are separate studies available for those under 18 and individuals over 65, comprising a total of 143 studies altogether."

Answered by AI

What is the primary goal behind conducting this medical trial?

"The primary goal of this research, to be assessed approximately 10-15 minutes after administering the investigational drug Bludigo, is identifying responders. Secondary measures consist of tracking adverse events and serious incidents among participants - notably detailing the percentage in each treatment arm encountering such events post-treatment; examining time for visualization of blue color in ureteral jets flow post-Bludigo™ administration (referred to as Time to Visualization or TTV); and observing alterations in vital signs following treatment, specifically focusing on subjects displaying significant changes."

Answered by AI

Am I eligible to participate in this research study?

"- Completion of a written IRB-approved informed consent form"

Answered by AI

Is the recruitment phase still ongoing for potential participants in this clinical trial?

"As per clinicaltrials.gov, this study is currently open for enrollment. It was initially listed on December 20th, 2023 and last revised on January 30th, 2024."

Answered by AI

What is the total number of participants being recruited for this research investigation?

"Indeed, data from clinicaltrials.gov affirms the ongoing patient recruitment for this medical trial. Initially shared on December 20th, 2023, the last revision was made on January 30th, 2024. The study aims to enroll a total of 48 participants at one designated site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Patient's With Renal Impairment
2023. "Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Patient's With Renal Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06085183.
~32 spots leftby Jun 2025
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