About this trial
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
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Intelligent Pressure and Temperature-Controlled Ureteroscope System
- Conventional Ureteroscope