Comparing three single-use flexible ureteroscopes for treating kidney stones
A Comparative Study of Performance and Cost-effectiveness of Three Different Single-Use Flexible Ureteroscopes in the Management of Renal Stones: A Randomized Clinical Trial
This compares three single-use flexible ureteroscopes to see which gives the best results for adults aged 18–60 with kidney stones smaller than 20 mm.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07360353 on ClinicalTrials.gov |
What this trial studies
Retrograde intrarenal surgery (RIRS) with flexible ureteroscopy is the preferred treatment for renal stones under 20 mm, and this interventional study compares three single-use digital ureteroscope models (LithoVue, WiScope, and Scivita). Adult patients meeting inclusion criteria will undergo RIRS with one of the devices and investigators will record operative time, stone-free rate on follow-up imaging, postoperative complications, and device-related costs. Key eligibility criteria include age 18–60, renal stones <20 mm, and absence of active urinary infection or major uncontrolled comorbidities, with exclusions for pregnancy, renal failure, abnormal urinary anatomy, and prior open ureteric surgery. The trial is conducted at Ain Shams University Hospital in Cairo and focuses on practical performance and cost-effectiveness differences among available single-use devices.
Who should consider this trial
Good fit: Adults aged 18–60 with renal stones smaller than 20 mm who do not have active infection or major uncontrolled medical conditions are ideal candidates.
Not a fit: Patients with stones larger than 20 mm, active urinary tract infection, renal failure, pregnancy, uncontrolled comorbidities, abnormal urinary tract anatomy, or prior open ureteric surgery are unlikely to be eligible or to benefit from this device comparison.
Why it matters
Potential benefit: If one device proves superior or more cost-effective, patients could experience shorter procedures, fewer complications, and higher stone-free rates.
How similar studies have performed: Single-use ureteroscopes have been studied for safety and effectiveness, but direct head-to-head comparisons among multiple single-use models remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 to 60 years. * Presence of renal stones measuring less than 20 millimeters (mm). Exclusion Criteria: * Renal stones larger than 20 millimeters (mm). * Uncontrolled bleeding disorders or coagulopathies. * Active urinary tract infection. * Renal failure. * Uncontrolled diabetes mellitus, hypertension, or hepatic dysfunction. * Pregnancy. * Abnormal urinary tract anatomy or known ureteric stricture. * History of previous open ureteric surgery.
Where this trial is running
Cairo
- Ain Shams University hospital — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Hesham E Khayrallah, Resident — Ain Shams University
- Study coordinator: Hesham E Khayrallah, Resident
- Email: heshamkhayrallah111@gmail.com
- Phone: +201016704043
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.