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New treatment option for Ureter Injury
Official title Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
ClinicalTrials.gov ID: NCT06085183
What this study is testing
What is Indigotindisulfonate sodium 0.8%?
Indigotindisulfonate sodium 0.8% is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for ureter injury.
Also referred to as Bludigo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- people between ≥ 18 and ≤ 85 years old
- people who signed a written IRB approved, informed consent form
- people 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...
- Normal people: eGFR of ≥90 mL/min
You likely can't join if
- people with eGFR \<15 mL/min or expected need for dialysis in the near future, or having only 1 kidney
- people 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
- people, as assessed by the Investigator, with conditions/concomitant diseases precluding their safe participation in this study (e.g., major systemic...
- Unable to meet specific protocol requirements (e.g., scheduled visits) or subject is uncooperative or has a condition that could lead to...
- Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly...
See the full eligibility criteria
- people between ≥ 18 and ≤ 85 years old
- people who signed a written IRB approved, informed consent form
- people 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. Subject's renal...
- Normal people: eGFR of ≥90 mL/min
- Mild renal impairment: eGFR 60 to 89 mL/min
- Moderate renal impairment: eGFR 30 to 59 mL/min
- Severe renal impairment: eGFR 15 to 29 mL/min people with normal renal function that are judged to be in good health based on medical history, physical examination, vital signs, and laboratory safety tests performed at...
- people with eGFR \<15 mL/min or expected need for dialysis in the near future, or having only 1 kidney
- people 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
- people, as assessed by the Investigator, with conditions/concomitant diseases precluding their safe participation in this study (e.g., major systemic diseases)
- Unable to meet specific protocol requirements (e.g., scheduled visits) or subject is uncooperative or has a condition that could lead to non-compliance with the study procedures
- Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- people with life expectancy \< 6 months
- Requirement for concomitant treatment that could bias primary evaluation.
- people who are pregnant or breast-feeding
The study team makes the final eligibility decision.
Where it's taking place
- Albany, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Albany, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.