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

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Feb 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of ureteroscope, which is a special tool used during surgery to remove kidney stones, especially when there is also an infection present. The main goal is to see if this new ureteroscope, which can control pressure and temperature, is safer and more effective than the standard tool currently used. Researchers want to find out if using this intelligent system results in fewer complications after surgery and better success in clearing the stones.

To be eligible for this trial, participants should be between the ages of 18 and 75 and have been diagnosed with kidney stones that are between 10 to 20 millimeters in size, along with a confirmed urinary tract infection. Those who join the study will have surgery using either the new ureteroscope or the standard one, and they will be monitored afterward for any complications and how well the stones are cleared. Participants will also have follow-up visits to check on their recovery. It's important to note that not everyone will qualify for the trial, as certain health conditions can exclude participation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 ≤ Age ≤ 75 years old, regardless of gender, able to tolerate surgery;
• • 2. ASA I-III;
• • 3. 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;
• • 4. Confirmed urinary tract infection, indicated by positive urine leukocytes and nitrite, or positive urine culture, with appropriate antibiotic treatment administered preoperatively;
• • 5. Those who voluntarily participate and sign an informed consent form.
• Exclusion Criteria:
• • 1. Uncontrollable systemic hemorrhagic disease;
• • 2. Severe spinal deformities, severe hip joint deformities, and difficulty in lithotomy position;
• • 3. Uncontrolled acute urinary tract infections;
• • 4. Any intracavitary surgery caused by anatomical factors of the urinary system cannot be performed;
• • 5. Pregnant, planned pregnancy within 3 months, and lactating female patients;
• • 6. 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.