Treatment of Upper Urinary Tract Stones With a Diameter≤2cm by Intelligent Pressure-controlled Flexible Ureteroscope

Summary

The aim of this trial is to compare the efficacy and safety of flexible ureteroscope with intelligent control of renal pelvic pressure (FURL-ICP) and traditional flexible ureteroscope(f-URL) in the treatment of upper urinary stones ≤ 2cm in diameter. It is designed as a multicenter, parallel randomized controlled trial with two arms. At least 449 patients with upper urinary stones ≤ 2cm in diameter will be invited to participant in this study. Patients will be assigned to intervention group (FURL-ICP group) or control group (f-URL) by a simple random sampling technique with a rate of 1:1. The baseline of participants include demographic data, urine analysis, blood cell analysis, blood biochemical analysis, and urinary computer tomography (CT) with a slice thickness of 2mm. The primary outcomes are postoperative stone-free rate (SFR) of one month by CT scan and postoperative fever rate (body temperature \> 38.5 ℃ within 3 days after operation). Secondary outcomes include operating time, degree of ureteral injury, SFR of one day.

Conditions

• Urinary Calculi

Interventions

DEVICE

Flexible ureteroscope with intelligent control of renal pelvic pressure

After adjusting the UAS in suitable position, the pressure sensory and suctioning channels are connected to the irrigation and suctioning platform. After being injected with water, a zero calibration is performed for the pressure sensory system. A fully automatic mode is selected on the platform. The perfusion flow is set between 50 to 150 mL/min. The RPP control value is set between -15 to -5 mmHg. The renal pelvic pressure alarm value is set between 20 to 30mmHg. During the operation, a holmium laser is used to break stones into powder (fiber diameter 200 µm), and the flexible ureteroscopy is moved back and forward slightly to suck out the stone particles inside the sheath gap. Particles larger than the sheath gap but smaller than the UAS is sucked out by intermittently withdrawing the flexible ureteroscope without basket.

Sponsors & Collaborators

• First Affiliated Hospital of Jinan University

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• The Affiliated Ganzhou Hospital of Nanchang University

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Jiangxi Provincial People's Hopital

  collaborator OTHER

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• Fujian Provincial Hospital

  collaborator OTHER

• First People's Hospital of Yulin

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• Affiliated Hospital of Guangdong Medical University

  collaborator OTHER

• Guohua Zeng

  lead OTHER

Principal Investigators

• Guohua Zeng, Doctor · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-11

Primary Completion

2022-07-31

Completion

2022-07-31

Countries

• China

Study Locations