Bendable Suction Ureteral Access Sheath Versus Conventional Ureteral Access Sheath in Management of Renal Stones Using Flexible Ureteroscopy

Launched by MENOUFIA UNIVERSITY · Mar 1, 2025

Keywords

ClinConnect Summary

This clinical trial is comparing two types of ureteral access sheaths used during a procedure called flexible ureteroscopy to remove kidney stones. One is a traditional sheath, while the other is a new, tip-flexible suctioning sheath that can reach deeper into the kidney. The goal is to see if the new sheath makes the procedure safer and more effective, especially for patients with kidney stones that are 5-20 mm in size.

To participate in this trial, you need to have confirmed kidney stones and be eligible for flexible ureteroscopy. You should be willing to provide informed consent and have a normal or slightly altered kidney structure that allows the use of the access sheath. However, if you have an active urinary tract infection, certain health conditions, or if your stones are too large or difficult to access, you may not be eligible. If you join the trial, you can expect to receive one of the two types of sheaths during your procedure and will be monitored for safety and effectiveness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis: Radiologically confirmed renal stones (e.g., CT, ultrasound, or X-ray).
• • Stone size within a specific range (e.g., 5-20 mm).
• • Indication for Treatment: patients indicated for flexible ureteroscopy due to renal stones.
• • Anatomical Suitability: normal or mildly altered renal anatomy that allows safe use of the access sheath.
• • Willingness to participate and provide written informed consent.
• Exclusion Criteria:
• • - Medical Conditions: Active urinary tract infection (UTI) or sepsis. Coagulopathy or inability to discontinue anticoagulation therapy. Significant comorbidities (e.g., severe cardiopulmonary disease). Pregnancy: Pregnant or breastfeeding individuals.
• * Anatomical or Surgical Factors:
• • Severe ureteral stricture or obstruction preventing sheath placement. Congenital abnormalities affecting the urinary tract. - Stone Factors: Stones larger than the sheath's operational limit (e.g., \>20 mm). Multiple stones in different calyces that cannot be accessed in one session.
• • - Previous Treatment: Recent (\<6 weeks) or repeated interventions for the same stones (e.g., prior lithotripsy or ureteroscopy).