Comparing two types of ureteral access sheaths for treating kidney stones
Bendable Suction Ureteral Access Sheath Versus Conventional Ureteral Access Sheath in Treatment of Renal Stones Using Flexible Ureteroscopy: a Randomized Clinical Trial
This study is testing whether a new bendable suction tool works better than a standard tool for helping patients with kidney stones get them removed safely during a specific procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Menoufia University Academic / other |
| Locations | 1 site (Shebin Elkom, Menoufia) |
| Trial ID | NCT06862141 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a bendable suction ureteral access sheath compared to a conventional ureteral access sheath in managing renal stones through flexible ureteroscopy. The study focuses on patients diagnosed with radiologically confirmed renal stones, specifically those with stones sized between 5-20 mm. Participants will undergo treatment using either type of sheath to determine which approach yields better outcomes in terms of stone removal and patient safety. The trial aims to enhance the minimally invasive treatment options available for nephrolithiasis.
Who should consider this trial
Good fit: Ideal candidates are patients with radiologically confirmed renal stones sized between 5-20 mm who are indicated for flexible ureteroscopy.
Not a fit: Patients with active urinary tract infections, severe comorbidities, or stones larger than 20 mm may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the effectiveness and safety of kidney stone removal procedures for patients.
How similar studies have performed: Other studies have shown promising results with similar minimally invasive techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Shebin Elkom, Menoufia
- Faculty of Medicine, Menoufia University — Shebin Elkom, Menoufia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed Kamal Omar
- Email: kimo_81eg@yahoo.com
- Phone: +201066949454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.