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3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency (UP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04228445
Recruitment Status : Not yet recruiting
First Posted : January 14, 2020
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Prove pharm

Brief 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

Condition or disease Intervention/treatment Phase
Ureter Injury Drug: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8% Drug: Saline spray Phase 3

Detailed Description:
This is an open-label, randomized, multicenter study to evaluate the efficacy, safety, and pharmacokinetics of two doses (2.5 mL and 5.0 mL) of 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium solution for injection when used as an aid in the determination of ureteral patency. Study will enroll up to 116 subjects from approximately 10 study centers in the United States.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: An Open-Label Study of Two Different Doses of 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution When Used as an Aid for Ureteral Patency
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : October 1, 2020

Arm Intervention/treatment
Experimental: HIGH DOSE
48 subjects randomly treated with 5 mL of drug
Drug: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%
Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.

Drug: Saline spray
Placebo

Experimental: LOW DOSE
48 subjects randomly treated with 2.5 mL of drug
Drug: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%
Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.

Drug: Saline spray
Placebo

Placebo Comparator: Saline
96 subjects treated with 5 ml of saline than crossover to treatment arm
Drug: Saline spray
Placebo




Primary Outcome Measures :
  1. 3-point Ureteral Orifice Visualization Scale (UOVS) determination of ureteral patency. [ Time Frame: 10 minutes ]

    Visualization will be measured by a 3-point Ureteral Orifice Visualization

    Scale (UOVS):

    1. = non-visualization
    2. = inadequate/equivocal visualization
    3. = adequate/unequivocal visualization of the urine jet stream after administration of test age



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04228445


Contacts
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Contact: Todd Koch 610.601.8600 todd.koch@provepharm.com

Sponsors and Collaborators
Prove pharm
Investigators
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Study Director: Todd Koch Prove pharm

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Responsible Party: Prove pharm
ClinicalTrials.gov Identifier: NCT04228445    
Other Study ID Numbers: PVP-19IC01
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No