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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Postoperative Complication Rate
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Prior to the surgery, it is necessary to select the surgical technique and follow the trial protocol by opening an envelope in the specified sequence. This trial protocol follows a "single blind" format, meaning that the researcher is aware of the surgical method while the subject remains unaware.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 ≤ Age ≤ 75 years old, regardless of gender, able to tolerate surgery;
- •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.
排除标准
- •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.
研究组 & 干预措施
Intelligent Pressure and Temperature-Controlled Ureteroscope System
Participants in this arm will undergo surgery using the Intelligent Pressure and Temperature-Controlled Ureteroscope System, which monitors and adjusts intrarenal pressure and temperature in real-time to ensure safe and effective lithotripsy.
干预措施: Intelligent Pressure and Temperature-Controlled Ureteroscope System (Device)
Conventional Ureteroscope
Participants assigned to this arm will undergo surgery with a conventional ureteroscope. The procedure involves standard ureteroscopic lithotripsy without real-time pressure or temperature monitoring.
干预措施: Conventional Ureteroscope (Device)
结局指标
主要结局
Postoperative Complication Rate
时间窗: Assessed at 48 hours and 1 month postoperatively.
This composite outcome measure includes the incidence of the following complications: 1. Fever: Defined as body temperature ≥38℃. 2. Urinary Sepsis: An increase in the Sequential Organ Failure Assessment (SOFA) score by ≥2 points postoperatively. 3. Septic Shock: Requires vasopressors to maintain mean arterial pressure ≥65 mmHg after adequate fluid resuscitation, with blood lactate concentration \>2 mmol/L 4. Pain: Assessed using the Numeric Rating Scale (NRS) within 48 hours postoperatively, recording the need for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) or other analgesic treatment. 5. Renal subcapsular or perirenal hematomaL: Diagnosed by Computed Tomography (CT) or other imaging within 30 days postoperatively. The composite postoperative complication rate will be calculated as the number of patients with at least one complication divided by the total number of patients in the study, multiplied by 100 to obtain a percentage.
Stone Free Rate
时间窗: Assessed at 1 month postoperatively.
This is defined as the proportion of patients with no residual stones or residual stones ≤2mm in diameter and asymptomatic, as confirmed by renal CT at 1 month postoperatively.
次要结局
- Stone Clearance Rate at 48 hours postoperatively(Assessed at 48 hours postoperatively.)
- Intraoperative Complications Rate(Assessed at 2 hours after the surgical procedure.)
- Concentration of postoperative infection markers(Assessed at 48 hours postoperatively during hospitalization.)
- Intraoperative Pressure(Assessed 2 hours after the surgical procedure.)
- Intraoperative Temperature(Assessed at 2 hours after the surgical procedure.)
- Postoperative Hospital Stay(Assessed at 24 hours after patients leaving the hospital)
- Surgical and Lithotripsy Time(Assessed at 24 hours postoperatively.)
研究者
Xu Kewei
Principal Investigator, Clinical Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University