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Набор скоро начнётся NCT07463157

FANS vs Standard Ureteral Access Sheath in fURS

Без фазы С лечением Renal Calculi

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Standard ureteral access sheath, Flexible and Navigable Suction (FANS) Ureteral Access Sheath.
Кому может быть актуально
Состояния в реестре: Renal Calculi. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Comparative Study on the Efficacy of the Ureteral Access Sheath With Integrated Suction FANS Versus the Standard Sheath in Patients With Renal Calculi Undergoing Ureterorenoscopy and Laser Lithotripsy: a Prospective, Randomized, Interventional, Single-center Study

Обзор

This is a prospective, interventional single blinded, randomized, single-center study designed to compare the efficacy of a ureteral access sheath with integrated suction (FANS) versus a standard ureteral access sheath (UAS) in patients undergoing ureterorenoscopy and laser lithotripsy for renal stones. The hypothesis is that the use of the FANS device improves stone-free rates and reduces postoperative infectious complications compared to the standard sheath.

Подробное описание

Single-center, prospective, randomized, interventional, single blinded study. Participants with renal calculi undergoing ureterorenoscopy and laser lithotripsy will be randomized in a 1:1 ratio to receive either a standard ureteral access sheath (UAS) or the FANS (Flexible and Navigable Suction) sheath. Randomization will be stratified by stone characteristics, specifically stone density (≤1000 vs \>1000 HU) and stone volume (\<500 vs ≥500 mm³), as recorded on preoperative imaging, to reduce potential imbalance between study arms.

Вмешательства

  • Устройство Standard ureteral access sheath
    Participants undergo flexible ureterorenoscopy and laser lithotripsy using a standard ureteral access sheath according to institutional practice.
  • Устройство Flexible and Navigable Suction (FANS) Ureteral Access Sheath
    The Flexible and Navigable Suction (FANS) ureteral access sheath (Elephant-II), which enables active suction during flexible ureterorenoscopy and laser lithotripsy.

Первичные конечные точки

  • Radiological stone-free rate (absence of residual fragments >=4 mm) assessed by low-dose non-contrast CT scan [Срок оценки: Within 3 months (+/- 1 month) post-procedure]

Критерии участия

Критерии включения

  • Participant is willing and able to provide written informed consent before any study-specific procedures are performed.
  • Male or female, aged 18 years or older.
  • Diagnosed with renal calculi ≥5 mm in diameter, confirmed by imaging, and eligible for fURS with laser lithotripsy according to European Association of Urology (EAU) guidelines.
  • In stable general health and fit for elective endoscopic surgery under general anesthesia.
  • Willing and able to comply with all study-related procedures, including follow-up imaging and clinical assessments.

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Критерии исключения

  • Solitary kidney (monorenal patients).
  • Untreated positive urine culture or ongoing urinary tract infection not resolved with appropriate antibiotic therapy prior to surgery.
  • Known anatomical abnormalities of the urinary tract that may interfere with ureteroscopic access or device placement (e.g., ureteral stricture, congenital malformations).
  • Pregnancy or breastfeeding at the time of enrollment or planning pregnancy during the study period. In all female patients, a Gravindex test is performed on the day of admission; contraceptive measures are not required
  • Concomitant ureteral stone
  • Ureteral stenosis
  • Known allergy or hypersensitivity to materials used in the investigational or control ureteral access sheath.
  • Any severe comorbid condition (e.g., uncontrolled cardiovascular disease, severe coagulopathy, active malignancy) that in the opinion of the investigator would interfere with study participation or increase procedural risk.
  • Any psychological, cognitive, or social condition that may limit the ability to provide informed consent or comply with follow-up procedures.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

Италия · 1 центр
  • IRCCS Ospedale San Raffaele — Milan

Идентификаторы

NCT: NCT07463157 · CLEAR-URS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗