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Using Retrograde Intrarenal Surgery for Managing Staghorn Renal Stones.

Using Bendable Tip-suction Ureteral Access Sheath Compared to Conventional Sheath in Managing Renal Staghorn Stones A Randomized Prospective Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07342361
Enrollment
100
Registered
2026-01-15
Start date
2026-01-20
Completion date
2026-12-01
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Calculi

Keywords

staghorn calculi, retrograde intrarenal surgery, Ureteral access sheath, Suction

Brief summary

This prospective, randomized study is comparing the safety and efficacy of using two types of ureteral access sheaths in managing staghorn renal stones by retrograde intrarenal surgery.

Detailed description

Staghorn renal calculi is a complex type of renal calculi characterized by their filling of the renal pelvis and branching into all or part of the renal calyces. Percutaneous nephrolithotomy (PCNL) is currently the recommended primary treatment option for staghorn renal calculi. However, the procedure has significant drawbacks, including invasiveness, postoperative bleeding, infection, prolonged hospitalization, and slow recovery. Retrograde Intrarenal Surgery (RIRS), an effective minimally invasive procedure, has become the first-line treatment for stones smaller than 2cm. With advancements in endoscopic equipment and techniques, RIRS is also being gradually utilized for the treatment of staghorn renal calculi in patients who are not suitable for PCNL. Ureteral access sheath (UAS) is an important tool for the endourologist. Advantages of using a UAS in ureteroscopy include: ena¬bling repeated passage of the ureteroscope while mini¬mizing damage, improving the flow of irrigation fluid and visualization within the ureter, reducing operative times, reducing the costs of procedures and improving the effectiveness of surgery. Intending to overcome the shortages of RIRS, a patented ureter access sheath with features of suction and bendable-tip is designed. The tip of the innovated ureteral access sheath can reach the target calyx along with the flexible ureteroscope. The adjustable continuous negative pressure suction ensures sufficient irrigation speed and maintains a clear surgical field of view, while effectively removing fragmented stones and dust, and reducing the thermal energy generated by laser lithotripsy.

Interventions

PROCEDURERetrograde intrarenal surgery

Retrograde intrarenal surgery with using laser for management of renal staghorn stones

Sponsors

Helwan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Safety of the surgical techniqueDuring surgery to one month after surgeryEvaluating and comparing the incidence of operative and postoperative complications

Secondary

MeasureTime frameDescription
The efficacy of the surgeryOne month after surgeryStone-free rates of the patients will be evaluated by computed tomography after surgery.

Countries

Egypt

Contacts

CONTACTAhmed H Elsergany, MSc.
dr_sergany2014@hotmail.com+20 1151405155
PRINCIPAL_INVESTIGATORAhmed H Elsergany, MSc

Helwan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026