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Study never started
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| Name | Class |
|---|---|
| Megan Billow | UNKNOWN |
| Graham Chapman | UNKNOWN |
| Sangeeta Mahajan | UNKNOWN |
| Alex Soriano |
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To determine the safety profile of sodium fluorescein in women undergoing cystoscopy during gynecologic surgery. To determine if either oral phenazopyridine or sodium fluorescein result in shorter cystoscopy times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Fluorescein | Active Comparator | Patients will receive an intravenous dose of 0.25 mL of 10% (500 mg, 5 mL) sodium fluorescein at the time of cystoscope insertion, for a total dose of 25 mg. Cystoscopy will be performed in the standard fashion during the course of the operation. |
|
| oral phenazopyridine | Active Comparator | Patients randomized to the phenazopyridine arm will be given a 200 mg pill with a sip of water in the pre-operative area 1 hour before their scheduled procedure. Cystoscopy will be performed in the standard fashion during the course of the operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium fluorescein | Drug |
| ||
| phenazopyridine |
| Measure | Description | Time Frame |
|---|---|---|
| differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of participants with intra-operative and immediate and post-operative treatment-related adverse events as assessed by CTCAE v4.0 | 12 months |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D019793 | Fluorescein |
| D010621 | Phenazopyridine |
| ID | Term |
|---|---|
| D005452 | Fluoresceins |
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Sherif El-Nashar | UNKNOWN |
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|
| D009930 |
| Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |