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Access Sheaths With Aspiration for Renal RetrOgrade Surgery, Randomized CompArative Outcomes
Sponsor: Hospitales Universitarios Virgen del Rocío
Summary
The goal of this clinical trial is to learn whether the ClearPetra ureteral access sheath (Coloplast) is more effective than the Navigator ureteral access sheath (Boston Scientific) in treating intrarenal kidney stones of 1-3 cm in adult patients undergoing flexible ureteroscopy (RIRS). The main questions it aims to answer are: Does ClearPetra achieve a higher stone-free rate at 1 month post-intervention compared to Navigator, as assessed by non-contrast abdominal-pelvic CT scan? Does ClearPetra reduce total surgical time compared to Navigator? Does ClearPetra lower the retreatment rate at 3 months compared to Navigator? Does ClearPetra present a rate of clinically significant complications (Clavien-Dindo ≥ II) that is lower than or similar to Navigator? Researchers will compare flexible ureteroscopy using the ClearPetra vacuum-assisted flexible ureteral access sheath to flexible ureteroscopy using the Navigator standard rigid ureteral access sheath, to see if ClearPetra leads to higher stone clearance rates while maintaining a comparable safety profile. Participants will: Undergo flexible ureteroscopy (RIRS) using one of two randomly assigned ureteral access sheaths (ClearPetra or Navigator), determined by computer-generated randomization immediately before surgery Have a non-contrast abdominal-pelvic CT scan at 1 month post-intervention to assess stone-free status Have a non-contrast abdominal-pelvic CT scan at 3 months post-intervention to evaluate residual fragments and the need for retreatment Attend follow-up visits at 1 month and 3 months post-surgery for clinical assessment and complication recording The study will be conducted at the Urology Department of Hospital Universitario Virgen del Rocío (Seville, Spain), a tertiary reference centre. A total of 156 patients will be randomized in a 1:1 ratio (78 per group), with pre-defined subgroup analyses stratified by stone size (1-2 cm vs. \>2 cm). The outcome assessor evaluating CT images for stone-free rate will be blinded to treatment allocation (single-blind).
Official title: ACCESS SHEATHS WITH ASPIRATION FOR RETROGRADE RENAL SURGERY, RANDOMIZED COMPARATIVE OUTCOMES
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2026-09-15
Completion Date
2030-05
Last Updated
2026-07-01
Healthy Volunteers
No
Interventions
ClearPetra ureteral access sheath
Tip-flexible ureteral access sheath with integrated continuous vacuum aspiration system (Coloplast). Placed transurethrally prior to flexible ureteroscopy to maintain stable ureteral access and actively evacuate stone fragments and irrigation fluid throughout the RIRS procedure. Used in combination with laser lithotripsy (Holmium:YAG or Thulium) for fragmentation of intrarenal stones of 1-3 cm. Accessory instruments (retrieval basket, stone cone) employed per standardised intraoperative protocol.
Navigator ureteral access sheath
Standard rigid ureteral access sheath without active aspiration mechanism (Boston Scientific). Placed transurethrally prior to flexible ureteroscopy to maintain stable ureteral access during the RIRS procedure. Used in combination with laser lithotripsy (Holmium:YAG or Thulium) for fragmentation of intrarenal stones of 1-3 cm. Accessory instruments (retrieval basket, stone cone) employed per standardised intraoperative protocol.
Locations (1)
Virgen del Rocio University Hospital
Seville, Seville, Spain