Comparing steerable and conventional access sheaths for treating small kidney stones
Flexible Ureteroscopy With Steerable Versus Conventional Flexible and Navigable Suction Ureteral Access Sheath (FANS) Utility in Less Than 2cm Lower Pole Stones Treatment: a Multicenter, Randomized Superiority Trial (SCULPT Trial)
NA · The First Affiliated Hospital of Guangzhou Medical University · NCT06898216
This study is testing a new flexible tool for removing small kidney stones to see if it works better and is safer than the standard method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Guangzhou Medical University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06898216 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized trial compares the efficacy and safety of a novel steerable flexible and navigable suction ureteral access sheath (FANS) against a conventional FANS for treating lower pole renal stones that are 2 cm or smaller. The steerable FANS features an active deflection mechanism that enhances maneuverability, potentially improving access to challenging anatomical areas. A total of 400 patients will be enrolled from 20 high-volume urological centers in China, with outcomes focusing on success rates, operative time, and complication rates. The trial aims to address the limitations of conventional methods in managing lower pole stones effectively.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with a single lower pole renal stone of 2 cm or less.
Not a fit: Patients with anatomical abnormalities of the urinary tract or multiple stones may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced complications for patients with lower pole kidney stones.
How similar studies have performed: Other studies have shown promise in using innovative access devices for kidney stone treatment, but this specific steerable approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18-75 years * Diagnosed with a single lower pole renal stone ≤2 cm by CT * American Society of Anesthesiology (ASA) score of 1-3 * Ability to provide written informed consent * Willingness and ability to comply with trial procedures and follow-up Exclusion Criteria: * Patients with urinary tract anatomical abnormalities (e.g., horseshoe kidney, ileal conduit) * Untreated urinary tract infection * Presence of multiple stones or stones located outside the lower pole * Absolute contraindications to flexible ureteroscopy * Inability to understand or complete trial documentation
Where this trial is running
Guangzhou, Guangdong
- Department of Urology, The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Guohua Zeng, M.D. — The First Affiliated Hospital of Guangzhou Medical University
- Study coordinator: Guohua Zeng, M.D.
- Email: gzgyzgh@vip.sina.com
- Phone: 13622754991
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.
Conditions: Kidney Stones, flexible ureteroscopy, flexible and navigable suction ureteral access sheath, FANS, lower pole, renal stones