- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03730389
External Physical Vibration Lithecbole(EPVL) Versus Traditional Treatment for 4-10 mm Ureteral Stone
External Physical Vibration Lithecbole(EPVL) Versus Traditional Treatment for 4-10 mm Ureteral Stone: A Multi-center Prospective Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guohua Zeng, Ph.D and M.D.
- Phone Number: +86 13802916676
- Email: gzgyzgh@vip.tom.cn
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510230
- Recruiting
- Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
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Principal Investigator:
- Guohua Zeng, Ph.D & MD.
-
Contact:
- Guohua Zeng, Ph.D & MD.
- Phone Number: +86 13802916676
- Email: gzgyzgh@vip.sina.com
-
Sub-Investigator:
- Chao Cai, PH.D & MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults age 18 to 70 years
- 4-10 mm single ureteral calculi
- Normal serum creatinine
- ASA grading: 1-2 levels.
Exclusion Criteria:
- 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);
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EPVL Group
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.
|
Using the the way of external physical vibration to promote separation of stones from ureteral mucosa and promoting the excretion of ureteral stones
|
No Intervention: Traditional Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Stone Expulsion
Time Frame: 14 days
|
The stone discharge rate of the two group
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Stone Passage
Time Frame: 14 days
|
Time to stone elimination in days in patients with spontaneous elimination
|
14 days
|
The rate of renal colic
Time Frame: 14 days
|
the mean rate of renal colic between the two groups
|
14 days
|
Required Analgesics
Time Frame: 14 days
|
the need for slow-released diclofenac tablet
|
14 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPVL for 4-10mm ureteral stone
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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