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

NCT ID: NCT06841523

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2028-04-01

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.

Conditions

Ureterolithiasis; Renal Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Intelligent Pressure and Temperature-Controlled Ureteroscope System

Intervention Type: DEVICE

RIRS procedure for upper ureteral or renal stone lithotripsy with Intelligent Pressure and Temperature-Controlled Ureteroscope System

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.

Group Type: ACTIVE_COMPARATOR

Conventional Ureteroscope

Intervention Type: DEVICE

RIRS procedure for upper ureteral or renal stone lithotripsy with conventional ureteroscope

Interventions

Intelligent Pressure and Temperature-Controlled Ureteroscope System

RIRS procedure for upper ureteral or renal stone lithotripsy with Intelligent Pressure and Temperature-Controlled Ureteroscope System

Intervention Type: DEVICE

Conventional Ureteroscope

RIRS procedure for upper ureteral or renal stone lithotripsy with conventional ureteroscope

Intervention Type: 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Xu Kewei

Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kewei Xu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Locations

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Kewei Xu, MD, PhD

Role: CONTACT

xukewei@mail.sysu.edu.cn

+86-13632331628

Other Identifiers

SYSKY-2024-1120-02

Identifier Type: -

Identifier Source: org_study_id