Back to resultsComparison Of External Physical Vibration Lithecbole(EPVL) In Different Time After Retrograde Intrarenal Surgery(RIRS)
Primary Purpose
Calculi
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3 days after
10days after
EPVL performed in30days after RIRS
Sponsored by
About this trial
This is an interventional supportive care trial for Calculi focused on measuring stones, external physical vibration lithecbole
Eligibility Criteria
Inclusion Criteria:
1.Age of 18-75 years;
Exclusion Criteria:
1.Urinary tract anomalies, stricture or obstruction;
Sites / Locations
- The Second Affiliated Hospital of Zhengzhou University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Experimental
Arm Label
3
10
30
Arm Description
Patients in 3 days
Patients in10ys
Patients in10ys
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Extracorporeal physical vibration complications
Complication is defined as any adverse event occurred
Full Information
NCT ID
NCT02890225
First Posted
August 25, 2016
Last Updated
April 28, 2018
Sponsor
Second Affiliated Hospital of Zhengzhou University
1. Study Identification
Unique Protocol Identification Number
NCT02890225
Brief Title
Comparison Of External Physical Vibration Lithecbole(EPVL) In Different Time After Retrograde Intrarenal Surgery(RIRS)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Zhengzhou University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calculi
Keywords
stones, external physical vibration lithecbole
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3
Arm Type
Other
Arm Description
Patients in 3 days
Arm Title
10
Arm Type
Other
Arm Description
Patients in10ys
Arm Title
30
Arm Type
Experimental
Arm Description
Patients in10ys
Intervention Type
Procedure
Intervention Name(s)
3 days after
Intervention Description
in 3 days after RIRS.
Intervention Type
Procedure
Intervention Name(s)
10days after
Intervention Description
in10 days after RIRS.
Intervention Type
Procedure
Intervention Name(s)
EPVL performed in30days after RIRS
Intervention Description
Patients in Group C undergo EPVL in630days after RIRS.
Primary Outcome Measure Information:
Title
Change from stone free rate(SFR) with different follow-up periods
Description
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.
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.
Secondary Outcome Measure Information:
Title
Extracorporeal physical vibration complications
Description
Complication is defined as any adverse event occurred
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Age of 18-75 years;
Exclusion Criteria:
1.Urinary tract anomalies, stricture or obstruction;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EB Wang, PH.D
Organizational Affiliation
Second Affiliated Hospital of Zhengzhou University
Official's Role
Study Chair
Facility Information:
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450014
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Of External Physical Vibration Lithecbole(EPVL) In Different Time After Retrograde Intrarenal Surgery(RIRS)
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