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RECRUITING Not applicable ClinicalTrials.gov

Direct In-Scope Suction Versus Standard Flexible Ureterorenoscopy

Sponsor: Hitit University • ClinicalTrials.gov ID: NCT07864194

Registry updated: 2026-10-07
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Description

This prospective study aims to compare the clinical, perioperative, and postoperative outcomes of flexible ureterorenoscopy using a direct in-scope suction system (DISS) with standard flexible ureterorenoscopy in patients undergoing retrograde intrarenal surgery for renal or proximal ureteral stones. A total of 70 patients will be enrolled, with 35 patients in each group. The study will assess postoperative infectious complications, including fever, systemic inflammatory response syndrome (SIRS), and sepsis, as well as operative parameters, length of hospital stay, reoperation, and stone-free status. Stone-free status will be assessed by non-contrast computed tomography four weeks after surgery.

Interventions

  • Standard flexible ureterorenoscope (Device)
    A 7.5 Fr reusable Storz Flex-X2 flexible ureterorenoscope without direct in-scope suction will be used for retrograde intrarenal surgery. Stone fragmentation will be performed with a Holmium:YAG laser through a 9.5/11.5 Fr ureteral access sheath.
  • Flexible ureterorenoscope with direct in-scope suction (Device)
    A 7.5 Fr single-use Claritron flexible ureterorenoscope equipped with direct in-scope suction will be used for retrograde intrarenal surgery. Suction through the scope will be available during irrigation and Holmium:YAG laser lithotripsy. A 9.5/11.5 Fr ureteral access sheath will be used.

Eligibility criteria

Inclusion Criteria: * Adults aged 18 years or older. * A single stone located in the kidney or proximal ureter. * Scheduled to undergo retrograde intrarenal surgery (RIRS) by the study's surgical team. Exclusion Criteria: * Multiple renal or proximal ureteral stones. * Age younger than 18 years. * Pregnancy. * Preoperative urinary tract infection. * Bleeding diathesis.

Conditions

Renal Stone Disease

Locations

  • Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye — Çorum, Çorum, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record