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

NCT06862141 | Recruiting FDA Device

• 1 other identifier: FANS protocol
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary calculus is a globally recognized urological condition, with prevalence rates ranging from 1% to 13% across different geographical regions (1) Therapeutic approaches for renal calculi encompass extracorporeal shock wave lithotripsy (ESWL) and minimally invasive endoscopic surgical techniques, such as percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS). Treatment plans depend on the characteristics of calculi, patient factors, surgeon experience and the condition of medical centers. According to the guidelines of American Urologic Association (AUA) and European Association of Urology (EAU), patients with a burden of less than 20 mm in kidney calculi can choose RIRS as the frst-line surgical treatment with good stone-free rate (SFR). (2, 3) The application of RIRS for urinary stones has increased signifcantly, and the indications have expanded due to developments in minimally invasive technology and equipment. (4) With the development of stone retrieval devices and miniaturized fexible ureteroscopes, RIRS is more widely used for treating renal calculi, even for high burden stones. (5, 6) The application of ureteral access sheath (UAS) in RIRS can improve surgical vision, reduce intrarenal pressure (IRP), and decrease postoperative infectious complications. (7-9) Several reports have demonstrated the superiority of suctioning UAS, including shorter operation time, higher SFR and lower incidence of infectious complications compared with traditional ureteral access sheath, but none of these suctioning UAS can reach the renal calyces. (10-12) A novel tip-flexible suctioning ureteral access sheath with flexible terminal was designed, which delivered the tip of the ureteral access sheath to renal calyces. However, data comparing novel tip-flexible suctioning ureteral access and traditional ureteral access sheath is lacking in RIRS. Therefore, we designed a prospective controlled analysis to compare the efficacy and safety of novel tip-flexible suctioning ureteral access sheath and traditional ureteral access sheath combined with flexible ureteroscope (FURS) in treating renal calculi.

Conditions

Nephrolithiasis; Flexible Ureteroscopy

Outcome Measures

Primary Outcomes (1)

• Immediate stone free rate

  measured by the number of cases has the status of No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1 are defined as stone free.

  one day postoperative

Secondary Outcomes (5)

• 3 month stone free rate

  3 months postoperatively

• duration of hospital stay

  2 weeks

• secondary intervention

  3 months

• complications

  3 months

• costs

  3 months postoperatively

Study Arms (2)

bendable suction ureteral access sheath

EXPERIMENTAL

this group will undergo flexible ureteroscopy using bendable suction ureteral access sheath

Device: bendable suction ureteral access sheath

conventional ureteral access sheath

EXPERIMENTAL

this group will undergo flexible ureteroscopy using conventional ureteral access sheath

Device: conventional suction ureteral access sheath

Interventions

bendable suction ureteral access sheath DEVICE

flexible ureteroscopy will be done using bendable suction ureteral access sheath

bendable suction ureteral access sheath

conventional suction ureteral access sheath DEVICE

flexible ureteroscopy will be done using conventional suction ureteral access sheath

conventional ureteral access sheath

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Faculty of Medicine, Menoufia University

Shebin Elkom, Menoufia, 35111, Egypt

RECRUITING

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Central Study Contacts

Mohamed Kamal Omar

CONTACT

+201066949454; kimo_81eg@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant of urology , urology department , menoufia university

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 6, 2025
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-02

Locations

EG (1)