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

April 28, 2018 updated by: Second Affiliated Hospital of Zhengzhou University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450014
        • The Second Affiliated Hospital of Zhengzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1.Age of 18-75 years;

Exclusion Criteria:

1.Urinary tract anomalies, stricture or obstruction;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 3
Patients in 3 days
Procedure: 3 days after
in 3 days after RIRS.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Zhengzhou University

Investigators

  • Study Chair: EB Wang, PH.D, Second Affiliated Hospital of Zhengzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 28, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zhengzhou

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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