Ureter InjuryPhase 3UPNCT04228445
3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency
A Phase 3 study testing 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8% and Saline spray in people with Ureter Injury, run by Prove pharm at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ureter Injury
- What is being tested?
- 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8% and Saline spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2020to 3 Jun 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- Subjects with life expectancy < 6 months;
- Requirement for concomitant treatment that could bias primary evaluation.
- Subjects who are pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Ureter Injury
- Being tested
- 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%, Saline spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%Drug
Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.
Saline sprayDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| HIGH DOSE | Experimental | 48 subjects randomly treated with 5 mL of drug Receives: Drug: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%; Drug: Saline spray |
| LOW DOSE | Experimental | 48 subjects randomly treated with 2.5 mL of drug Receives: Drug: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%; Drug: Saline spray |
| Saline | Placebo comparator | 96 subjects treated with 5 ml of saline than crossover to treatment arm Receives: Drug: Saline spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Jet Conspicuity Score
The urine jet conspicuity score provided by the blinded central review process as assessed by the following 5-point ordinal scale.
- = No jet observed
- = Weak jet, little color contrast
- = Color contrast or significant jet flow
- = Strong jet flow with good color contrast
- = Strong jet flow with striking contrast in color
Measured: 10 minutes
Secondary outcomes (3)
Percentage of Responders
A subject was a responder when there was ≥1-point improvement in the urine jet conspicuity scores following the indigo carmine versus saline treatment (indigo carmine - saline ≥1) and the conspicuity score following the indigo carmine treatment was 3, 4, or 5. The responder criteria were assessed separately for each ureter for each subject based on the blinded central reviewer's conspicuity score.
Measured: 10 Minutes
Physician Satisfaction Agreement Scale
After the completion of the procedure, the surgeon rated the experience of using indigo carmine for each subject using the 5-point PSAS, in which:
"Compared to the use of saline treatment, my ability to assess ureteral patency was improved after the addition of indigo carmine."
- = Strongly Agree
- = Agree
- = Neither Agree nor Disagree
- = Disagree
- = Strongly Disagree
The surgeon was considered satisfied with the indigo carmine treatment if his/her rating was either a 1 (strongly agree) or a 2 (agree); otherwise, the surgeon was considered unsatisfied with the indigo carmine treatment.
Measured: 10 Minutes
Time to Visualization
Time to visualization (minutes) of blue color in the ureteral jets flow following indigo carmine treatment
Measured: 10 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start13 Feb 2020
- Primary completion3 Jun 2021
- Study completion3 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ureter InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prove pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Koch, Study director, Prove pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228445
- Sponsor's protocol ID
- PVP-19IC01
- Acronym
- UP
- Status last verified
- Nov 2022
- First submitted
- 23 Dec 2019
- Last updated
- 30 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04228445
- Acronym / sponsor ID
- UP / PVP-19IC01
- Conditions
- Ureter Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Prove pharmIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 3 Jun 2021 (actual)
- Study completion
- 3 Jun 2021 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Posted 30 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIGH DOSE | Experimental | Drug: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%, Drug: Saline spray48 subjects randomly treated with 5 mL of drug |
| LOW DOSE | Experimental | Drug: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%, Drug: Saline spray48 subjects randomly treated with 2.5 mL of drug |
| Saline | Placebo comparator | Drug: Saline spray96 subjects treated with 5 ml of saline than crossover to treatment arm |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | HIGH DOSE, LOW DOSE |
| Saline sprayPlacebo | Drug | HIGH DOSE, LOW DOSE, Saline |
Primary outcome
Urine Jet Conspicuity Score
Time frame: 10 minutes
The urine jet conspicuity score provided by the blinded central review process as assessed by the following 5-point ordinal scale. 1. = No jet observed 2. = Weak jet, little color contrast 3. = Color contrast or significant jet flow 4. = Strong jet flow with good color contrast 5. = Strong jet flow with striking contrast in color
3 secondary outcomes
Percentage of Responders
Time frame: 10 Minutes
Physician Satisfaction Agreement Scale
Time frame: 10 Minutes
Time to Visualization
Time frame: 10 Minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Koch study director
Prove pharm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8% and Saline spray in people with Ureter Injury, run by Prove pharm at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Jet Conspicuity Score (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.