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Renal CalculiNCT02643134

External Physical Vibration Lithecbole Versus Traditional Row of Stone After Extracorporeal Shockwave Lithotripsy(ESWL)

A study testing extracorporeal shockwave lithotripsy and External Physical Vibration Lithecbole in people with Renal Calculi, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The traditional stone row method comprises increasing exercise, drink lots of water, drug row of stone and stone row position. External physical vibration lithecbole(EPVL) is a non-invasive device active row of stone, the researchers hope that through this test prospective clinical study to evaluate the effectiveness… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Renal Calculi
What is being tested?
extracorporeal shockwave lithotripsy and External Physical Vibration Lithecbole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
Aug 2015to Jul 2016
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

  • Age of 18-65 years;
  • The diameter of calculus is less than or equal to 15mm;
  • Renal or upper ureteral calculus;
  • There's no urinary tract obstruction below stones, and stones didn't cause complete urinary tract obstruction;
  • Stones are fragmented successfully on single session of ESWL, and the diameter of any of fragments is less than 6mm;
  • Normal renal function,

Who cannot join

  • Couldn't tolerate EPVL;
  • Urinary tract anomalies, stricture or obstruction;
  • Calculus in diverticulum;
  • Severe hydronephosis;
  • Combined with acute urinary tract infection;
  • Coagulation abnormalities;
Show all 9Show fewer
  • Morbid obesity(BMI>35kg/m2);
  • Patients with ureteral stent;
  • Stones aren't fragment successfully, or the diameter of at least one fragment is more than 6mm ;

Trial locations and contacts

1 site in 1 country.

Guohua Zeng, PH.D and M.D contact

+86 13802916676

gzgyzgh@vip.tom.com

China1 site, 1 recruiting
  • Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510230

    Guohua Zeng, Ph.D and M.D, +86 13802916676, gzgyzgh@vip.tom.com

    Guohua Zeng, Ph.D and M.D

    Recruiting

Other trials in China

About this study

Official title: External Physical Vibration Lithecbole Contrast With the Traditional Row of Stone Effect After ESWL: A Multi-center Prospective Randomized Controlled Trial

The traditional stone row method comprises increasing exercise, drink lots of water, drug row of stone and stone row position. External physical vibration lithecbole(EPVL) is a non-invasive device active row of stone, the researchers hope that through this test prospective clinical study to evaluate the effectiveness of in vitro physical vibration row of stones after extracorporeal shockwave lithotripsy(ESWL) treatment of stones discharged, thereby improving after ESWL stone clearance rate.

Read the detailed description

To evaluate the efficacy and safety of external physical vibration lithecbole(EPVL) for the treatment after ESWL treatment of stones discharged,thereby improving after extracorporeal shockwave lithotripsy(ESWL) stone clearance rate. Investigators will do a multi-centers randomized controlled trial(RCT),and investigators plan to perform this study in 10 hospitals,which are the First Affiliated Hospital of Guangzhou Medical University of China, Department of Urology, The Second Affiliated Hospital of Zhengzhou University of China, Jiangsu Province Hospital, Hubei Province Hospital, Zhongshan Hospital, Tongji Hospital,Hubei provincial people's Hospital,Guilin 181 Hospital,the People' Hospital of Huzhou,The People' Hospital of Shaoyang.

Investigators plan to beginning their study August 2015 and end at July 2016. One hundred and eighty patients with ESWL postoperative residual stone will be enrolled in this study. By simple random sampling technique, all the patients will be assigned to the segment of natural stone row group or physical row of stone group, compared two groups of patients with stone clearance rate and complications, Investigators hope that through this test, improve stone clearance rate after ESWL.

Number:

180cases(90 cases in control group, 90 cases in EPVL group)

Grouping methods:

In this trial, investigators will use equilibrium randomization methods that generate random numerical code table, according to the table, patients are randomly assigned to different groups.

Evaluating indicator Stone-free rate in 4 weeks after ESWL. Incidence rate of complications and adverse reactions after EPVL(fever, hematuria, etc).

Trial method:

Examination before ESWL: blood routine, urine routine, renal function(Cre,BUN), coagulation function; intravenous pyelography(IVP) or CT (radiolucent calculus).

ESWL

Record: duration, frequency, voltage, times.

Method of control group(group1):

ESWL without EPVL; Reexamined by abdominal plain film(KUB) or CT (radiolucent calculus) right after ESWL;

After leaving hospital(without drugs), patients should follow the measures bellowed:

  1. the amount of fluid intake is more than 2000ml/d
  2. increase physical activity
  3. rest in position on uninjured side, patients with lower renal calyx calculus need to invert body.

Method of EPVL group(group2):

Start the treatment of EPVL: the amount of fluid intake is about 1000-2000ml, start the treatment of EPVL when patent's bladder is filling; Reexamined by abdominal plain film(KUB) or CT(radiolucent calculus) right after EPVL;

Record: patients' date, treatment procedure and outcome;

After leaving hospital(without drugs), patients should follow the measures bellowed:

  1. the amount of fluid intake is more than 2000ml/d
  2. increase physical activity
  3. rest in position on uninjured side, patients with lower renal calyx calculus need to invert body;

Follow up timing: return hospital respectively in 1,2 and 4 weeks after EPVL.

Follow up project Laboratory testing: routine urinalysis; Imaging examination: KUB or kidney CT scan (radiolucent calculus) Complications and adverse reactions. Data gathering Fill in follow up table data; Radiological images; IVP or kidney CT scan before ESWL; Reexamined by KUB (radiopaque calculus) or CT (radiolucent calculus) right after EPVL. If stones have been eliminated completely in patients with radiolucent calculus before or at the fourth week of follow-up, investigators must provide kidney CT scan.

Conditions
Renal Calculi
Being tested
extracorporeal shockwave lithotripsy, External Physical Vibration Lithecbole
Keywords
ESWL, EPVL, PDI(Percussion,Diuresis,Inversion), Randomized Controlled Trial(RCT)
Medical subject headings
Kidney Calculi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • extracorporeal shockwave lithotripsyProcedure or surgery

    Patients in Group 1 undergo extracorporeal shockwave lithotripsy(ESWL).

  • External Physical Vibration LithecboleDevice

    Also called Friend-I External Physical Vibration Lithecbole

    Multi-dimensional physical harmonic vibration inertial guidance technology

Study groups in NCT02643134
Study groupRoleWhat they receive
Group 1OtherPatients in Group 1 undergo extracorporeal shockwave lithotripsy(ESWL).
Receives: Procedure: extracorporeal shockwave lithotripsy
Group 2OtherPatients in Group 2 undergo external physical vibration lithecbole for the treatment after extracorporeal shockwave lithotripsy(ESWL).A multi-dimensional physical harmonic vibration inertial guidance technology
Receives: Device: External Physical Vibration Lithecbole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stone free rate (SFR)

    Primary SFR is assessed by abdominal plain film (KUB)at 1,2,4 weeks after ESWL. Stone-free status are defined as either the absence of any residual stone fragments.

    Measured: return hospital respectively in 1,2 and 4 weeks after ESWL

Secondary outcomes (1)
  1. extracorporeal physical vibration complications

    Complication is defined as any adverse event occurred

    Measured: return hospital respectively in 1,2 and 4 weeks after ESWL

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJul 2016 (estimated)
  4. Study completionJul 2016 (estimated)

Resources

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
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02643134
Sponsor's protocol ID
MRER(53)2015
Status last verified
Aug 2015
First submitted
4 Dec 2015
Last updated
31 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing extracorporeal shockwave lithotripsy and External Physical Vibration Lithecbole in people with Renal Calculi, run by The First Affiliated Hospital of Guangzhou Medical University 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 6 inclusion and 9 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 31 Dec 2015. 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.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stone free rate (SFR) (time frame: return hospital respectively in 1,2 and 4 weeks after ESWL). 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 31 Dec 2015.

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