An interventional study of External Physical Vibration Lithecbole (EPVL) in Ureteral Calculi, sponsored by Guohua Zeng. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-11-05.
Sponsored by Guohua Zeng · Not applicable, Interventional, and Treatment
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.
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.
120 studies on the registry are indexed under Ureteral Calculi; 23 are open to participants now.
This study's planned enrollment of 208 is above the median of 100 across 97 interventional studies indexed under Ureteral Calculi.
Browse Ureteral Calculi studies →Guohua Zeng is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Device: External Physical Vibration Lithecbole (EPVL)
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.
Using the the way of external physical vibration to promote separation of stones from ureteral mucosa and promoting the excretion of ureteral stones
Number of Participants With Stone Expulsion
The stone discharge rate of the two group
Time frame: 14 days
Time to Stone Passage
Time to stone elimination in days in patients with spontaneous elimination
Time frame: 14 days
The rate of renal colic
the mean rate of renal colic between the two groups
Time frame: 14 days
Required Analgesics
the need for slow-released diclofenac tablet
Time frame: 14 days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Guohua Zeng