Using Retrograde Intrarenal Surgery for Managing Staghorn Renal Stones.

January 30, 2026 updated by: Ahmed Hassan Ahmed Hassan Elsergany, Helwan University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group (1): Retrograde intrarenal surgery using a bendable tip-suction ureteral access sheath
During retrograde intrarenal surgery, an ureteral access sheath with bendable tip & connected to suction system will be used.
Procedure: Retrograde intrarenal surgery
Retrograde intrarenal surgery with using laser for management of renal staghorn stones
Placebo Comparator: Group (2): Retrograde intrarenal surgery using a conventional ureteral access sheath
During retrograde intrarenal surgery, a conventional ureteral access sheath will be used.
Procedure: Retrograde intrarenal surgery
Retrograde intrarenal surgery with using laser for management of renal staghorn stones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the surgical technique
Time Frame: During surgery to one month after surgery
Evaluating and comparing the incidence of operative and postoperative complications
During surgery to one month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helwan University

Investigators

  • Principal Investigator: Ahmed H Elsergany, MSc, Helwan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2026

Primary Completion (Estimated)

October 10, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 129-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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