Status:
COMPLETED
Investigating Oral Agents for Urine Staining to Facilitate Intraoperative Observation of Ureteral Jets
Lead Sponsor:
Texas Tech University Health Sciences Center
Conditions:
Ureteral Injury
Eligibility:
FEMALE
21-75 years
Phase:
EARLY_PHASE1
Brief Summary
Recently, Indigo Carmine and Methylene Blue have been the standard agents to visualize ureteral jets during intraoperative cystoscopy. However, due to a national shortage of Indigo Carmine and Methyle...
Detailed Description
This is a 3 arm, double- blinded, randomized, controlled pilot study to look at the ease of evaluating ureteral patency at the time of intraoperative cystoscopy and comparing effects and possible adve...
Eligibility Criteria
Inclusion
- Age 21 to 75 years.
- Female patients ages who are scheduled to undergo gynecologic procedures where cystoscopy/need to determine ureteral patency may be indicated.
- Being seen in the department of Texas Tech OB/GYN.
- Willing to be randomized.
- Have not taken, or willing to stop taking pyridium or riboflavin at least 7 days prior to surgery.
Exclusion
- Female patients who are found to have one of the following conditions based on their medical history: Active Inflammation of the Liver, Glomerulonephritis, Uremia, Kidney Disease, Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency, Anemia from Pyruvate Kinase and G6PD Deficiency.
- Patients who have allergies to pyridium, riboflavin, or vitamin B1 riboflavin.
- Patients who, for whatever reason, did not receive the product they were randomized to receive.
Key Trial Info
Start Date :
June 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03432572
Start Date
June 27 2018
End Date
June 30 2020
Last Update
August 11 2020
Active Locations (1)
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1
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430