External Physical Vibration Lithecbole(EPVL) Versus Traditional Treatment for 4-10 mm Ureteral Stone

NCT ID: NCT03730389

Last Updated: 2018-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Ureteral Calculi

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

External Physical Vibration Lithecbole(EPVL) for ureteral stone
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

External Physical Vibration Lithecbole (EPVL)

Intervention Type DEVICE

Using the the way of external physical vibration to promote separation of stones from ureteral mucosa and promoting the excretion of ureteral stones

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. Pregnant or isolated kidney patients
2. Moderate or severe hydronephrosis
3. History of ureteral stricture
4. Multiple ureteral stones;
5. Acute urinary tract infection
6. Those who are taking α-receptor, calcium channel blocker or chinese medicine stone shovel
7. Dysfunction of blood coagulation
8. Obese patients (body mass index \> 28 kg / m2);
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Guohua Zeng

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Guohua Zeng

Vice president

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guohua Zeng, PH.D & MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Guangzhou Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Guohua Zeng, Ph.D and M.D.

Role: CONTACT

+86 13802916676

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Guohua Zeng, Ph.D & MD.

Role: primary

+86 13802916676

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EPVL for 4-10mm ureteral stone

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.