Comparing steerable and conventional access sheaths for treating small kidney stones
Official title: 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)
Run by The First Affiliated Hospital of Guangzhou Medical University · NCT06898216 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | The First Affiliated Hospital of Guangzhou Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | March 16, 2025 |
| Main results expected | January 1, 2026 |
| Study ends | March 1, 2026 |
| Registry record updated | March 27, 2025 |
| Trial ID | NCT06898216 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18-75 with a single lower pole renal stone of 2 cm or less.
✕Probably not a fit
Patients with anatomical abnormalities of the urinary tract or multiple stones 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 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.
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 gone: Other studies have shown promise in using innovative access devices for kidney stone treatment, but this specific steerable approach is relatively novel.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Modified Mini-PCNL vs Standard PCNL for Complex Kidney Stones
This study tests whether a smaller 20 Fr access in modified mini-PCNL can match the stone-clearing success of the standard 24 Fr PCNL in adults with complex kidney stones.
-
Aspirating vs non-aspirating ureteral access sheath in RIRS for kidney stones
This trial tests whether using an aspirating ureteral access sheath during retrograde intrarenal surgery improves stone clearance and reduces complications compared with a non-aspirating sheath in adults with small kidney stones.
-
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.
-
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.
-
Negative-pressure suction during flexible ureteroscopy to reduce fluid absorption and infections
This test will see if using a negative-pressure suction sheath during retrograde intrarenal surgery for adults with kidney stones reduces how much irrigation fluid their bodies absorb and lowers the risk of postoperative infections.
-
Outcomes and costs with the HugeMed 6.3 Fr flexible ureteroscope
This trial will test whether the HugeMed 6.3 Fr flexible ureteroscope gives similar stone-free results while lowering costs compared with traditional flexible ureteroscopes in adults having RIRS for stones up to 2.5 cm.
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.