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.
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
- Type of treatment
- Medical device, Surgery or procedure
- 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.
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 and M.D, +86 13802916676, gzgyzgh@vip.tom.com
Guohua Zeng, Ph.D and M.D
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:
- the amount of fluid intake is more than 2000ml/d
- increase physical activity
- 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:
- the amount of fluid intake is more than 2000ml/d
- increase physical activity
- 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 group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Patients in Group 1 undergo extracorporeal shockwave lithotripsy(ESWL). Receives: Procedure: extracorporeal shockwave lithotripsy |
| Group 2 | Other | Patients 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.
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)
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.
- First posted31 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CalculiStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Guohua Zeng, PH.D and M.D, Study chair, The First Affiliated Hospital of Guangzhou Medical
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Physical Vibration Lithecbole Contrast With the Traditional Row of Stone Effect After ESWL: A Multi-center Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02643134
- Acronym / sponsor ID
- MRER(53)2015
- Conditions
- Renal Calculi
- Keywords
- ESWL, EPVL, PDI(Percussion,Diuresis,Inversion), Randomized Controlled Trial(RCT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 31 Dec 2015 (estimated)
- 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 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.
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:
- the amount of fluid intake is more than 2000ml/d
- increase physical activity
- 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:
- the amount of fluid intake is more than 2000ml/d
- increase physical activity
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Procedure: extracorporeal shockwave lithotripsyPatients in Group 1 undergo extracorporeal shockwave lithotripsy(ESWL). |
| Group 2 | Other | Device: External Physical Vibration LithecbolePatients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- Couldn't tolerate EPVL;
- Urinary tract anomalies, stricture or obstruction;
- Calculus in diverticulum;
- Severe hydronephosis;
- Combined with 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 |
|---|---|---|
| extracorporeal shockwave lithotripsyPatients in Group 1 undergo extracorporeal shockwave lithotripsy(ESWL). | Procedure or surgery | Group 1 |
| External Physical Vibration LithecboleAlso: Friend-I External Physical Vibration LithecboleMulti-dimensional physical harmonic vibration inertial guidance technology | Device | Group 2 |
Primary outcome
Stone free rate (SFR)
Time frame: return hospital respectively in 1,2 and 4 weeks after ESWL
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.
1 secondary outcome
extracorporeal physical vibration complications
Time frame: return hospital respectively in 1,2 and 4 weeks after ESWL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
Related trials for Renal Calculi
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
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 and M.D study chair
The First Affiliated Hospital of Guangzhou Medical
1 site in 1 country: see every site and its status.
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.