| NCT ID | NCT03638999 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Washington University School of Medicine |
| Condition | Ureteral Stent Placement |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2018-07-31 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2018-07-31 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * 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 mg is allowed. * 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.
Contact & Investigator
Alana Desai, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT03638999 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ureteral Stent Placement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03638999 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03638999 currently recruiting?
Yes, NCT03638999 is actively recruiting participants. Contact the research team at desaia@email.wustl.edu for enrollment information.
Where is the NCT03638999 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT03638999 clinical trial?
NCT03638999 is sponsored by Washington University School of Medicine. The principal investigator is Alana Desai, MD at Washington University School of Medicine. The trial plans to enroll 36 participants.