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NCT Number: NCT07342361

Using Retrograde Intrarenal Surgery for Managing Staghorn Renal Stones.

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Helwan University

Cairo, 11795, Egypt

Location status: Recruiting

Location contact

Mohammed H Ali, MD

CONTACT

[email protected]

+20 1005116684

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retrograde Intrarenal Surgery

Procedure

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

Primary outcomes

  1. Safety of the surgical technique

    Time frame: During surgery to one month after surgery

    Evaluating and comparing the incidence of operative and postoperative complications

Secondary outcomes

  1. The efficacy of the surgery

    Time frame: One month after surgery

    Stone-free rates of the patients will be evaluated by computed tomography after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed H Elsergany, MSc.

CONTACT

[email protected]

+20 1151405155

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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