Clinical trial NCT06841523: An Intelligent Pressure and Temperature Control Ureteral Soft Scope System for Treating Stones With Infection.
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ureterolithiasis
Renal Calculi
Keywords: Ureteral Stone
renal stone
Ureteroscopy
Upper urinary tract stones with concurrent infection
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Intelligent Pressure and Temperature-Controlled Ureteroscope System Arm 2: Conventional Ureteroscope
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

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.

Primary outcomes:
measure: Postoperative Complication Rate
timeFrame: Assessed at 48 hours and 1 month postoperatively.
measure: Stone Free Rate
timeFrame: Assessed at 1 month postoperatively.
Secondary outcomes:
measure: Stone Clearance Rate at 48 hours postoperatively
timeFrame: Assessed at 48 hours postoperatively.
measure: Intraoperative Complications Rate
timeFrame: Assessed at 2 hours after the surgical procedure.
measure: Concentration of postoperative infection markers
timeFrame: Assessed at 48 hours postoperatively during hospitalization.
measure: Intraoperative Pressure
timeFrame: Assessed 2 hours after the surgical procedure.
measure: Intraoperative Temperature
timeFrame: Assessed at 2 hours after the surgical procedure.
measure: Postoperative Hospital Stay
timeFrame: Assessed at 24 hours after patients leaving the hospital
measure: Surgical and Lithotripsy Time
timeFrame: Assessed at 24 hours postoperatively.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Kewei Xu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: