CalculiNCT02890225
Comparison Of External Physical Vibration Lithecbole(EPVL) In Different Time After Retrograde Intrarenal Surgery(RIRS)
A study testing 3 days after, 10days after and EPVL performed in30days after RIRS in people with Calculi, run by Second Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to eliminate stone completely Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Calculi
- What is being tested?
- 3 days after, 10days after and EPVL performed in30days after RIRS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Mar 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Age of 18-75 years;
Who cannot join
- 1.Urinary tract anomalies, stricture or obstruction;
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014
About this study
Official title: Effect Of Renal Residual Stones c Treated By External Physical Vibration Lithecbole(EPVL) In m Different Time n After Retrograde Intrarenal w Surgery(RIRS):At y Multi-center z Prospective Randomized Controlled Trial
The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to eliminate stone completely
Read the detailed description
To evaluate the efficacy and safety of external physical vibration lithecbole for the treatment of residual stone in different time (3 days ,7 days and 14 days) after the operation of RIRS
- Conditions
- Calculi
- Being tested
- 3 days after, 10days after, EPVL performed in30days after RIRS
- Keywords
- stones, external physical vibration lithecbole
- Medical subject headings
- Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 days afterProcedure or surgery
in 3 days after RIRS.
10days afterProcedure or surgery
in10 days after RIRS.
EPVL performed in30days after RIRSProcedure or surgery
Patients in Group C undergo EPVL in630days after RIRS.
| Study group | Role | What they receive |
|---|---|---|
| 3 | Other | Patients in 3 days Receives: Procedure: 3 days after |
| 10 | Other | Patients in10ys Receives: Procedure: 10days after |
| 30 | Experimental | Patients in10ys Receives: Procedure: EPVL performed in30days after RIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from stone free rate(SFR) with different follow-up periods
Primary SFR is assessed by abdominal plain film （KUB）in different follow-up periods after operation. Stone-free status are defined as either the absence of any residual stone fragments.
Measured: Patients in group A and group B return hospital respectively in 1,2 and 4 weeks after RIRS,patients in group C return hospital respectively in 2 and 4 weeks after RIRS.
Secondary outcomes (1)
Extracorporeal physical vibration complications
Complication is defined as any adverse event occurred
Measured: Patients in group A and group B return hospital respectively in 1,2 and 4 weeks after RIRS,patients in group C return hospital respectively in 2 and 4 weeks after RIRS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EB Wang, PH.D, Study chair, Second Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890225
- Sponsor's protocol ID
- Zhengzhou
- Status last verified
- Apr 2018
- First submitted
- 25 Aug 2016
- Last updated
- 1 May 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 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Renal Residual Stones c Treated By External Physical Vibration Lithecbole(EPVL) In m Different Time n After Retrograde Intrarenal w Surgery(RIRS):At y Multi-center z Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02890225
- Acronym / sponsor ID
- Zhengzhou
- Conditions
- Calculi
- Keywords
- stones, external physical vibration lithecbole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 7 Sep 2016 (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 treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to eliminate stone completely
Detailed description
To evaluate the efficacy and safety of external physical vibration lithecbole for the treatment of residual stone in different time (3 days ,7 days and 14 days) after the operation of RIRS
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 | Other | Procedure: 3 days afterPatients in 3 days |
| 10 | Other | Procedure: 10days afterPatients in10ys |
| 30 | Experimental | Procedure: EPVL performed in30days after RIRSPatients in10ys |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Age of 18-75 years;
Key exclusion criteria (1 listed)
- 1.Urinary tract anomalies, stricture or obstruction;
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 |
|---|---|---|
| 3 days afterin 3 days after RIRS. | Procedure or surgery | 3 |
| 10days afterin10 days after RIRS. | Procedure or surgery | 10 |
| EPVL performed in30days after RIRSPatients in Group C undergo EPVL in630days after RIRS. | Procedure or surgery | 30 |
Primary outcome
Change from stone free rate(SFR) with different follow-up periods
Time frame: Patients in group A and group B return hospital respectively in 1,2 and 4 weeks after RIRS,patients in group C return hospital respectively in 2 and 4 weeks after RIRS.
Primary SFR is assessed by abdominal plain film （KUB）in different follow-up periods after operation. Stone-free status are defined as either the absence of any residual stone fragments.
1 secondary outcome
Extracorporeal physical vibration complications
Time frame: Patients in group A and group B return hospital respectively in 1,2 and 4 weeks after RIRS,patients in group C return hospital respectively in 2 and 4 weeks after RIRS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 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.
EB Wang, PH.D study chair
Second Affiliated Hospital of Zhengzhou 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 3 days after, 10days after and EPVL performed in30days after RIRS in people with Calculi, run by Second Affiliated Hospital of Zhengzhou 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from stone free rate(SFR) with different follow-up periods (time frame: Patients in group A and group B return hospital respectively in 1,2 and 4 weeks after RIRS,patients in group C return hospital respectively in 2 and 4 weeks after RIRS.). 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 1 May 2018.