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Идёт набор NCT07071948

A Single-Center Clinical Study on the Efficacy and Safety of VISOR

Без фазы С лечением Urolithiasis, Calcium Oxalate Kidney Stone

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: Multifunctional Integrated Flexible Ureteroscope.
Кому может быть актуально
Состояния в реестре: Urolithiasis, Calcium Oxalate, Kidney Stone. Базовые параметры: 18 лет — 80 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
Китай
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

A Single-Center Clinical Study on the Efficacy and Safety of Vortex Intelligence Stone Optimized Removal (VISOR)

Обзор

Goal of this trial: To test a new tool called VISOR in adults (aged 18-80) with 1-3 cm kidney or ureter stones. We want to see: 1. If it's safe and works well 2. If its built-in features (flushing/suction, pressure control, and stone-breaking/removal) help clear stones better while keeping surgery safe. Main questions: 1. Can the VISOR clear stones successfully (with fragments \<4 mm left) for at least 9 out of every 10 people within 24 hours after surgery? 2. Will serious problems (like severe infections or ureteral injuries) happen to no more than 1 in 20 people (5%)? 3. Can the device keep pressure inside the kidney below 30 mmHg (a safe level) during the entire surgery? What participants will do: Have stone removal surgery using VISOR (breaks and removes stones at the same time). Get a CT scan within 24 hours after surgery to check if stones are cleared. Return 4 weeks (±1 week) after surgery for: An imaging test (CT or ultrasound) A check for any health problems related to the surgery.

Вмешательства

  • Устройство Multifunctional Integrated Flexible Ureteroscope
    Investigational ureteroscope with three integrated functions: 1. Real-time pressure control: Continuous renal pelvic pressure monitoring with auto-adjustment of irrigation/aspiration flow to maintain pressure \<30 mmHg (safety threshold) 2. Simultaneous lithotripsy \& fragment removal: Holmium laser lithotripsy (200-365 μm fiber) coordinated with suction through working channel 3. Single-pass stone clearance: Designed to reduce residual fragments requiring secondary procedures Distinguishing f

Первичные конечные точки

  • 24-hour stone-free rate after Xinwell Scope lithotripsy [Срок оценки: within 24 hours postoperatively]
Вторичные конечные точки (5)
  • 1-month stone-free rate [Срок оценки: 28±7 days postoperatively]
  • Operative time [Срок оценки: During surgery]
  • Intraoperative renal pelvic pressure [Срок оценки: Continuous monitoring during lithotripsy]
  • Ureteral injury rate [Срок оценки: During surgery]
  • Postoperative complication rate [Срок оценки: 24h, 28 ±7 days , 1 month]

Критерии участия

Критерии включения

  • Patients with upper urinary tract calculi, where the maximum diameter of a single calculus or the cumulative diameter of multiple calculi is 1-3 cm
  • Patients who choose to undergo "flexible ureteroscopic holmium laser lithotripsy"
  • Aged 18-80 years, regardless of gender
  • Subjects without mental illness or language dysfunction, who can understand the details of this study and sign the informed consent form

Критерии исключения

  • Patients with ureteral stricture or a history of ureteral stricture
  • Patients with a history of open renal and/or ureteral surgery or laparoscopic surgery
  • Fever (body temperature ≥ 38℃) due to urinary tract infection or other reasons within one week before surgery
  • Pregnant women, lactating women, or women who are in the menstrual period
  • ASA classification > Grade 3: patients with severe systemic diseases, heart diseases, pulmonary insufficiency, and failure of important organ functions, etc., who cannot tolerate anesthesia or surgery
  • Patients with anatomical malformations such as polycystic kidney, horseshoe kidney, and ectopic kidney
  • Patients with abnormal coagulation function (e.g., international normalized ratio (INR) > 1.5 or platelet count < 80 × 10⁹/L)
  • Patients with failed sheath placement during surgery

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT07071948 · 2025-0324

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗