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

NCT06841523 | Not Yet Recruiting

• 1 other identifier: SYSKY-2024-1120-02
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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

Conditions

Ureterolithiasis; Renal Calculi

Keywords

Ureteral Stone; renal stone; Ureteroscopy; Upper urinary tract stones with concurrent infection

Outcome Measures

Primary Outcomes (2)

• Postoperative Complication Rate

  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.

  Assessed at 48 hours and 1 month postoperatively.

• Stone Free Rate

  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.

  Assessed at 1 month postoperatively.

Secondary Outcomes (7)

• 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.

Study Arms (2)

Intelligent Pressure and Temperature-Controlled Ureteroscope System

ACTIVE COMPARATOR

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.

Device: Intelligent Pressure and Temperature-Controlled Ureteroscope System

Conventional Ureteroscope

ACTIVE COMPARATOR

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.

Device: Conventional Ureteroscope

Interventions

Intelligent Pressure and Temperature-Controlled Ureteroscope System DEVICE

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

Intelligent Pressure and Temperature-Controlled Ureteroscope System

Conventional Ureteroscope DEVICE

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

Conventional Ureteroscope

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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;
• Those who voluntarily participate and sign an informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Ureterolithiasis; Kidney Calculi; Nephrolithiasis

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kewei Xu, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kewei Xu, MD, PhD

CONTACT

+86-13632331628; xukewei@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: Arm 1: Intelligent Pressure and Temperature-Controlled Ureteroscope System Arm 2: Conventional Ureteroscope

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 24, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)