Ureteral CalculiNCT03730389
External Physical Vibration Lithecbole(EPVL) Versus Traditional Treatment for 4-10 mm Ureteral Stone
A study testing External Physical Vibration Lithecbole (EPVL) in people with Ureteral Calculi, run by Guohua Zeng at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ureteral Calculi
- What is being tested?
- External Physical Vibration Lithecbole (EPVL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 1 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 to 70 years
- 4-10 mm single ureteral calculi
- Normal serum creatinine
- ASA grading: 1-2 levels.
Who cannot join
- 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);
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230
Guohua Zeng, Ph.D & MD., +86 13802916676, gzgyzgh@vip.sina.com
Guohua Zeng, Ph.D & MD.
About this study
Official title: External Physical Vibration Lithecbole(EPVL) Versus Traditional Treatment for 4-10 mm Ureteral Stone: A Multi-center Prospective Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Ureteral Calculi
- Being tested
- External Physical Vibration Lithecbole (EPVL)
- Keywords
- Ureteral Calculi, External Physical Vibration Lithecbole (EPVL), Efficacy, Safety
- Medical subject headings
- Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Physical Vibration Lithecbole (EPVL)Device
Using the the way of external physical vibration to promote separation of stones from ureteral mucosa and promoting the excretion of ureteral stones
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: External Physical Vibration Lithecbole (EPVL) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Stone Expulsion
The stone discharge rate of the two group
Measured: 14 days
Secondary outcomes (3)
Time to Stone Passage
Time to stone elimination in days in patients with spontaneous elimination
Measured: 14 days
The rate of renal colic
the mean rate of renal colic between the two groups
Measured: 14 days
Required Analgesics
the need for slow-released diclofenac tablet
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Aug 2018
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- External Physical Vibration Lithecbole(EPVL) for ureteral stone
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guohua Zeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Guohua Zeng, PH.D & MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730389
- Sponsor's protocol ID
- EPVL for 4-10mm ureteral stone
- Status last verified
- Nov 2018
- First submitted
- 2 Nov 2018
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Physical Vibration Lithecbole(EPVL) Versus Traditional Treatment for 4-10 mm Ureteral Stone: A Multi-center Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03730389
- Acronym / sponsor ID
- EPVL for 4-10mm ureteral stone
- Conditions
- Ureteral Calculi
- Keywords
- Ureteral Calculi, External Physical Vibration Lithecbole (EPVL), Efficacy, Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Guohua ZengUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- External Physical Vibration Lithecbole(EPVL) for ureteral stone
| Arm | Type | Receives |
|---|---|---|
| EPVL Group | Experimental | Device: External Physical Vibration Lithecbole (EPVL)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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults age 18 to 70 years
- 4-10 mm single ureteral calculi
- Normal serum creatinine
- ASA grading: 1-2 levels.
Key exclusion criteria (8 listed)
- Pregnant or isolated kidney patients
- Moderate or severe hydronephrosis
- History of ureteral stricture
- Multiple ureteral stones;
- Acute urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Physical Vibration Lithecbole (EPVL)Using the the way of external physical vibration to promote separation of stones from ureteral mucosa and promoting the excretion of ureteral stones | Device | EPVL Group |
Primary outcome
Number of Participants With Stone Expulsion
Time frame: 14 days
The stone discharge rate of the two group
3 secondary outcomes
Time to Stone Passage
Time frame: 14 days
The rate of renal colic
Time frame: 14 days
Required Analgesics
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guohua Zeng, PH.D & MD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Physical Vibration Lithecbole (EPVL) in people with Ureteral Calculi, run by Guohua Zeng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guohua Zeng, Ph.D and M.D. (+86 13802916676, gzgyzgh@vip.tom.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Stone Expulsion (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.