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Comparison Of External Physical Vibration Lithecbole(EPVL) In Different Time After Retrograde Intrarenal Surgery(RIRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890225
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Zhengzhou University

Brief Summary:
The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to eliminate stone completely

Condition or disease Intervention/treatment Phase
Calculi Procedure: 3 days after Procedure: 10days after Procedure: EPVL performed in30days after RIRS Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
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 Start Date : August 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
3
Patients in 3 days
Procedure: 3 days after
in 3 days after RIRS.

10
Patients in10ys
Procedure: 10days after
in10 days after RIRS.

Experimental: 30
Patients in10ys
Procedure: EPVL performed in30days after RIRS
Patients in Group C undergo EPVL in630days after RIRS.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
    Complication is defined as any adverse event occurred



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1.Age of 18-75 years;

Exclusion Criteria:

1.Urinary tract anomalies, stricture or obstruction;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890225


Locations
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China, Henan
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450014
Sponsors and Collaborators
Second Affiliated Hospital of Zhengzhou University
Investigators
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Study Chair: EB Wang, PH.D The Second Affiliated Hospital of Zhengzhou University
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Responsible Party: Second Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier: NCT02890225    
Other Study ID Numbers: Zhengzhou
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital of Zhengzhou University:
stones
external physical vibration lithecbole
Additional relevant MeSH terms:
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Calculi
Pathological Conditions, Anatomical