Managing staghorn kidney stones with retrograde intrarenal surgery
Official title: Using Bendable Tip-suction Ureteral Access Sheath Compared to Conventional Sheath in Managing Renal Staghorn Stones A Randomized Prospective Study
Run by Helwan University · NCT07342361 · Data updated 2026-11-12
This tests whether a new bendable, suction-enabled ureteral access sheath works better than a standard sheath during retrograde intrarenal surgery for adults with staghorn kidney stones.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Helwan University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | January 20, 2026 |
| Main results expected | October 10, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | February 3, 2026 |
| Trial ID | NCT07342361 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with partial or complete staghorn renal stones and normal renal function who are medically fit for RIRS and do not have active urinary infection or significant coagulation problems.
✕Probably not a fit
Patients with active or untreated urinary tract infection, abnormal coagulation, pregnancy, ureteral obstruction requiring other interventions, or those outside the 18–70 age range are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized comparison of two ureteral access sheaths used during retrograde intrarenal surgery (RIRS) for patients with partial or complete staghorn renal calculi. Participants are adults with normal renal function who are suitable for RIRS and without active urinary infection or coagulopathy; they are randomized to receive either a patented bendable-tip suction sheath or a standard sheath. Outcomes will include measures of safety and efficacy such as stone clearance, operative time, visualization/irrigation quality, and perioperative complications. The single-center trial is conducted at the Faculty of Medicine, Helwan University in Cairo.
Why it matters
Potential benefit: If successful, the new suction, bendable-tip sheath could improve stone clearance and visualization while shortening operative time and reducing complications for patients treated with RIRS.
How similar studies have gone: RIRS and use of ureteral access sheaths are established for smaller stones and improve irrigation and scope passage, but applying a suction-enabled, bendable-tip sheath to staghorn calculi is a newer approach with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients of both sexes. * Patient has a staghorn renal stone (complete or partial staghorn). * Normal renal function tests. * Congenital renal anomalies as horseshoe, pelvic or mal-rotated kidneys. Exclusion Criteria: * Abnormal coagulation profile. * Active or untreated urinary tract infection. * Age under 18 years or above 70 years. * Patient has a staghorn stone associated with other pathology which requires additional intervention, as ureteral stricture or ureteropelvic junction obstruction (UPJO). * Pregnancy.
Where it's running
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Faculty of medicine, Helwan University
Cairo, Egypt Recruiting
Study contacts
- Principal investigator: Ahmed H Elsergany, MSc — Helwan University
- Study coordinator: Ahmed H Elsergany, MSc.
- Email: dr_sergany2014@hotmail.com
- Phone: +20 1151405155
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.