Phase 3
N=121
3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency
Ureter Injury
Bottom Line
View on ClinicalTrials.gov: NCT04228445 ↗Enrolled (actual)
121
Serious AEs
1.7%
Results posted
Nov 2022
Primary outcome: Primary: Urine Jet Conspicuity Score — 4.1; 4.2; 2.5 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8% (Drug); Saline spray (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Prove pharm
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urine Jet Conspicuity Score |
4.1; 4.2; 2.5 | <0.0001 sig |
| SECONDARY Percentage of Responders |
43; 41; 6; 6 | — |
| SECONDARY Physician Satisfaction Agreement Scale |
44; 38; 5; 9 | — |
| SECONDARY Time to Visualization |
6.00; 5.93 | — |
Summary
To determine whether the use of 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution for injection provides a visualization advantage compared to saline when used as an aid in the determination of ureteral patency
Eligibility Criteria
Inclusion Criteria
- Subjects between ≥ 18 and ≤ 85 years old.
- Subjects who signed written, IRB approved, informed consent form.
- Subjects scheduled for urological or gynecological surgical procedures in which the patency of the ureter must be assessed by the surgeon during the procedure
Exclusion Criteria
- Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR <30 mL/min/1.73m2 (using the MDRD) or need for dialysis in the near future, or having only 1 kidney.
- Subjects with known severe hypersensitivity reactions to IC or other dyes including contrast agents.
- 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).
- 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;
- Subjects with life expectancy < 6 months;
- Requirement for concomitant treatment that could bias primary evaluation.
- Subjects who are pregnant or breast-feeding.
Data sourced from ClinicalTrials.gov (NCT04228445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.