NCT02890225

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

7 months

First QC Date

August 25, 2016

Last Update Submit

April 28, 2018

Conditions

Calculi

Keywords

stonesexternal physical vibration lithecbole

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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.

Study Arms (3)

3

OTHER

Patients in 3 days

Procedure: 3 days after

10

OTHER

Patients in10ys

Procedure: 10days after

30

EXPERIMENTAL

Patients in10ys

Procedure: EPVL performed in30days after RIRS

Interventions

3 days afterPROCEDURE

in 3 days after RIRS.

3
10days afterPROCEDURE

in10 days after RIRS.

10
EPVL performed in30days after RIRSPROCEDURE

Patients in Group C undergo EPVL in630days after RIRS.

30

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18-75 years;

You may not qualify if:

  • Urinary tract anomalies, stricture or obstruction;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450014, China

Location

MeSH Terms

Conditions

Calculi

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • EB Wang, PH.D

    Second Affiliated Hospital of Zhengzhou University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

September 7, 2016

Study Start

August 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2018

Last Updated

May 1, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)