Comparing two types of ureteral access sheaths for treating kidney stones
Official title: Bendable Suction Ureteral Access Sheath Versus Conventional Ureteral Access Sheath in Treatment of Renal Stones Using Flexible Ureteroscopy: a Randomized Clinical Trial
Run by Menoufia University · NCT06862141 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 172 (estimated) |
| Sponsor | Menoufia University Academic / other |
| Locations | 1 site (Shebin Elkom, Menoufia) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | December 1, 2025 |
| Study ends | February 1, 2026 |
| Registry record updated | March 11, 2025 |
| Trial ID | NCT06862141 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with radiologically confirmed renal stones sized between 5-20 mm who are indicated for flexible ureteroscopy.
✕Probably not a fit
Patients with active urinary tract infections, severe comorbidities, or stones larger than 20 mm may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with similar minimally invasive techniques, suggesting potential for success in this approach.
Who can join: the full rules
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 it's running
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Faculty of Medicine, Menoufia University
Shebin Elkom, Menoufia, Egypt Recruiting
Study contacts
- Study coordinator: Mohamed Kamal Omar
- Email: kimo_81eg@yahoo.com
- Phone: +201066949454
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Suction vs Conventional Ureteral Access Sheaths in Kidney Stone Surgery
This study tests whether using a suction ureteral access sheath during RIRS helps adults clear stones more often and potentially reduces operative time and infections compared with a conventional sheath.
-
Observation vs Upfront Surgery for Asymptomatic Kidney Stones in Children and Adults
This trial tests whether watching asymptomatic kidney stones or performing upfront surgery is better for reducing life disruption in patients aged 6 and older.
-
Tract Closure with Hemostatic Agent in PCNL
This trial tests whether applying a hemostatic agent during tract closure in PCNL helps reduce blood loss compared with balloon tamponade alone.
-
Suction to collapse the kidney's collecting system after RIRS (retrograde intrarenal surgery)
This trial will test whether actively suctioning the kidney's collecting system at the end of RIRS reduces early postoperative pain and infections for adults having kidney stone removal.
-
Early versus delayed shock wave treatment for leftover kidney stones after percutaneous nephrolithotomy
This trial tests whether doing extracorporeal shock wave lithotripsy (ESWL) early or waiting longer after PCNL helps clear leftover kidney stone fragments ≤15 mm with fewer complications.
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Compare two suction ureteroscope devices for kidney stones (FANS vs CVAC)
This study tests whether two new suction-enabled ureteroscopes (FANS and CVAC) lead to better stone clearance for adults with small to medium kidney stones compared to each other.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.