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临床试验/NCT03730389
NCT03730389Unknown不适用

External Physical Vibration Lithecbole(EPVL) Versus Traditional Treatment for 4-10 mm Ureteral Stone: A Multi-center Prospective Randomized Controlled Trial

Guohua Zeng1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2018年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
208
试验地点
1
主要终点
Number of Participants With Stone Expulsion

研究概览

简要总结

The investigator aims to perform a prospective and randomized controlled trial evaluating the safety and efficacy of External Physical Vibration Lithecbole(EPVL) in treating 4-10 mm ureteral stone.

详细描述

Patients with ureteral stones less than 10 mm, would receive observation for stone passage, not requiring immediate surgery. There are many studies evaluating the effect of Medical expulsive therapy in treating ureteral stones, including a-blockers, and calcium channel blockers. Most of shuties concluded that the benefit of a-blockers might be among those with larger (distal) stones. There is no good method for the removal of upper ureteral calculi, except drinking water and exercising.

Recently, a new extracorporeal physical vibrational lithecbole (EPVL) device named Friend-I EPVL (Zhengzhou Fu Jian Da Medical Instrument Co., Zhengzhou, China) has proven to be an effective treatment for upper urinary tract residual calculi. The device was approved by the Chinese food and drug administration in 2012. A Simple harmonic motion technology in multi-direction was applied. The Lateral acceleration was provided by the physical vibration device in the base through the harmonic vibration wave in the horizontal direction, which induces the urinary stone separate with the kidney or ureter, and expands a moving space for the stone. Meanwhile, an axial effect was produced to push the stone by the physical vibration device in the handle through the harmonic vibration wave in the multi- direction. So, we think that EPVL may be effective in treating ureteral stones.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults age 18 to 70 years
  • •4-10 mm single ureteral calculi
  • •Normal serum creatinine
  • •ASA grading: 1-2 levels.

排除标准

  • •Pregnant or isolated kidney patients
  • •Moderate or severe hydronephrosis
  • •History of ureteral stricture
  • •Multiple ureteral stones;
  • •Acute urinary tract infection
  • •Those who are taking α-receptor, calcium channel blocker or chinese medicine stone shovel
  • •Dysfunction of blood coagulation
  • •Obese patients (body mass index > 28 kg / m2);

研究组 & 干预措施

EPVL Group

Experimental

In treatment group, patients were given one to three sessions of External Physical Vibration Lithecbole therapy in two weeks. These patients were also instructed to drink a minimum of 2500 ml water daily and take more exercise.

干预措施: External Physical Vibration Lithecbole (EPVL) (Device)

Traditional Group

No Intervention

patients with 4-10mm ureteral stone, were treated by traditional treatment methods, including drinking a minimum of 2500 ml water daily and taking more exercise.

结局指标

主要结局

Number of Participants With Stone Expulsion

时间窗: 14 days

The stone discharge rate of the two group

次要结局

  • Required Analgesics(14 days)
  • Time to Stone Passage(14 days)
  • The rate of renal colic(14 days)

研究者

发起方
Guohua Zeng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Guohua Zeng

Vice president

The First Affiliated Hospital of Guangzhou Medical University

研究点 (1)

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