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New treatment option for Ureteral Stent Placement
Official title NSAIDs Stent Study
ClinicalTrials.gov ID: NCT03638999
What this study is testing
What is Ketorolac Trometamol 30Mg/1mL Injection?
Ketorolac Trometamol 30Mg/1mL Injection is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for ureteral stent placement.
Also referred to as Toradol IV/IM.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a pilot study to (1) evaluate the effect of Ketorolac on inflammatory response and its impact on stent related symptoms in patients undergoing stent placement procedure and (2) assess feasibility of recruitment, randomization, assessment procedures and implementation of the study intervention.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Over 18 years of age and willing and able to provide informed consent
- Patients with renal urolithiasis planning to undergo ureteral stent placement following ureteroscopic manipulation
You likely can't join if
- Patients requiring a bilateral stone procedure.
- Patients on a chronic non-steroidal anti-inflammatory drugs (NSAIDs) including Aspirin defined as any NSAIDs use for more than fifteen days within...
- Patients on any steroid therapy.
- Patients with prescription anti-inflammatory drugs.
- Patients with gastrointestinal ulcers.
- Patients with ureteral obstruction or stricture unrelated to stone disease.
See the full eligibility criteria
- Over 18 years of age and willing and able to provide informed consent
- Patients with renal urolithiasis planning to undergo ureteral stent placement following ureteroscopic manipulation
- Patients requiring a bilateral stone procedure.
- Patients on a chronic non-steroidal anti-inflammatory drugs (NSAIDs) including Aspirin defined as any NSAIDs use for more than fifteen days within thirty days prior to the procedure. Exception: use of daily Aspirin 81...
- Patients on any steroid therapy.
- Patients with prescription anti-inflammatory drugs.
- Patients with gastrointestinal ulcers.
- Patients with ureteral obstruction or stricture unrelated to stone disease.
- Patients with active urinary tract infection as evidence of untreated positive urine culture obtained prior to the procedure (as part of pre-operative testing).
- Patients with preexisting indwelling ureteral stent
- Patients who are pregnant or lactating.
- Patients with renal or liver impairment.
- Patients with concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would render the patient inappropriate for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.