An Intelligent Pressure and Temperature Control Ureteral Soft Scope System for Treating Stones With Infection.

Официальное название

Intelligent Pressure and Temperature Control Ureteral Soft Scope System for the Treatment of Upper Ureteral Stones Complicated With Infection in the Kidney and Upper Ureter: a Multicenter Randomized Controlled Clinical Study

Обзор

The goal of this clinical trial is to determine the efficacy and safety of a novel intelligent pressure and temperature-controlled ureteroscope system for treating renal and upper ureteral stones with concurrent infection. It will also assess its ability to reduce postoperative complications and improve stone clearance rates. The main questions it aims to answer are: Does the intelligent system lower the complication rate and enhance stone clearance compared to standard ureteroscopy? What safety issues or medical problems do participants experience when using the intelligent system? Researchers will compare the intelligent pressure and temperature-controlled ureteroscope system to a standard ureteroscope to evaluate its effectiveness in treating renal and upper ureteral stones. Participants will: Undergo surgery using either the intelligent system or a standard ureteroscope Be monitored for postoperative complications, stone clearance, and other relevant outcomes Participate in follow-up visits to assess recovery and treatment efficacy

Подробное описание

This study protocol describes a multi-center, prospective, randomized controlled trial with a non-inferiority design, aiming to assess the efficacy and safety of an intelligent pressure and temperature-controlled ureteroscope system for treating renal and upper ureteral stones with concurrent infection. A total of 288 patients will be randomized into two groups (1:1 ratio), with the intervention group receiving the intelligent system and the control group undergoing standard ureteroscopy. The primary endpoints are the complication rate and stone clearance rate at 1 month postoperatively, while secondary endpoints include short-term stone clearance, intraoperative and postoperative complications, infection markers, surgical time, and intraoperative pressure and temperature monitoring. The study will adhere to rigorous ethical standards and statistical analysis plans to provide robust evidence for the clinical application of this novel device.

Вмешательства

• Устройство Intelligent Pressure and Temperature-Controlled Ureteroscope System
  RIRS procedure for upper ureteral or renal stone lithotripsy with Intelligent Pressure and Temperature-Controlled Ureteroscope System
• Устройство Conventional Ureteroscope
  RIRS procedure for upper ureteral or renal stone lithotripsy with conventional ureteroscope

Первичные конечные точки

• Postoperative Complication Rate [Срок оценки: Assessed at 48 hours and 1 month postoperatively.]
• Stone Free Rate [Срок оценки: Assessed at 1 month postoperatively.]

Вторичные конечные точки (7)

• Stone Clearance Rate at 48 hours postoperatively [Срок оценки: Assessed at 48 hours postoperatively.]
• Intraoperative Complications Rate [Срок оценки: Assessed at 2 hours after the surgical procedure.]
• Concentration of postoperative infection markers [Срок оценки: Assessed at 48 hours postoperatively during hospitalization.]
• Intraoperative Pressure [Срок оценки: Assessed 2 hours after the surgical procedure.]
• Intraoperative Temperature [Срок оценки: Assessed at 2 hours after the surgical procedure.]
• Postoperative Hospital Stay [Срок оценки: Assessed at 24 hours after patients leaving the hospital]
• Surgical and Lithotripsy Time [Срок оценки: Assessed at 24 hours postoperatively.]

Критерии участия

Критерии включения

• 18 ≤ Age ≤ 75 years old, regardless of gender, able to tolerate surgery;
• ASA I-III;
• Patients who have been confirmed by bilateral renal/urinary tract CT to have upper ureteral or renal stones, single or multiple, with a cumulative maximum diameter of 10mm < cumulative maximum diameter ≤ 20mm, and are planning to undergo ureteroscopic lithotripsy for stone removal;
• Confirmed urinary tract infection, indicated by positive urine leukocytes and nitrite, or positive urine culture, with appropriate antibiotic treatment administered preoperatively;
• Those who voluntarily participate and sign an informed consent form.

Критерии исключения

• Uncontrollable systemic hemorrhagic disease;
• Severe spinal deformities, severe hip joint deformities, and difficulty in lithotomy position;
• Uncontrolled acute urinary tract infections;
• Any intracavitary surgery caused by anatomical factors of the urinary system cannot be performed;
• Pregnant, planned pregnancy within 3 months, and lactating female patients;
• The patients determined by the investigator to be unsuitable for this study include (but are not limited to): known to have human immunodeficiency virus (HIV) or AIDS; Suffering from mental illness; Infectious diseases.

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

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT06841523 · SYSKY-2024-1120-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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