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NCT Number: NCT02890225

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

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

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Key information

Conditions

Calculi Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450014, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1.Age of 18-75 years;

Exclusion criteria

1.Urinary tract anomalies, stricture or obstruction;

Treatment and study plan

3 days after

Procedure

in 3 days after RIRS.

10days after

Procedure

in10 days after RIRS.

EPVL performed in30days after RIRS

Procedure

Patients in Group C undergo EPVL in630days after RIRS.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Zhengzhou University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 7, 2016
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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