Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency
Recruiting
Phase 4
Interventional Study
Ureter Injury
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 116 (estimated)
- Sponsor
- Prove pharm · Industry
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About This Trial
This is a randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Bludigo when used as an aid in the determination of ureteral patency.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Subjects between ≥ 18 and ≤ 85 years old
* Subjects who signed a written IRB approved, informed consent form
* Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure
Exclusion Criteria:
* Subjects…
Contacts