NCT02643134

Brief Summary

The traditional stone row method comprises increasing exercise, drink lots of water, drug row of stone and stone row position. External physical vibration lithecbole(EPVL) is a non-invasive device active row of stone, the researchers hope that through this test prospective clinical study to evaluate the effectiveness of in vitro physical vibration row of stones after extracorporeal shockwave lithotripsy(ESWL) treatment of stones discharged, thereby improving after ESWL stone clearance rate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 31, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 31, 2015

Status Verified

August 1, 2015

Enrollment Period

11 months

First QC Date

December 4, 2015

Last Update Submit

December 28, 2015

Conditions

Renal Calculi

Keywords

ESWLEPVLPDI(Percussion,Diuresis,Inversion)Randomized Controlled Trial(RCT)

Outcome Measures

Primary Outcomes (1)

  • Stone free rate (SFR)

    Primary SFR is assessed by abdominal plain film （KUB）at 1,2,4 weeks after ESWL. Stone-free status are defined as either the absence of any residual stone fragments.

    return hospital respectively in 1,2 and 4 weeks after ESWL

Secondary Outcomes (1)

  • extracorporeal physical vibration complications

    return hospital respectively in 1,2 and 4 weeks after ESWL

Study Arms (2)

Group 1

OTHER

Patients in Group 1 undergo extracorporeal shockwave lithotripsy(ESWL).

Procedure: extracorporeal shockwave lithotripsy

Group 2

OTHER

Patients in Group 2 undergo external physical vibration lithecbole for the treatment after extracorporeal shockwave lithotripsy(ESWL).A multi-dimensional physical harmonic vibration inertial guidance technology

Device: External Physical Vibration Lithecbole

Interventions

extracorporeal shockwave lithotripsyPROCEDURE

Patients in Group 1 undergo extracorporeal shockwave lithotripsy(ESWL).

Group 1
External Physical Vibration LithecboleDEVICE

Multi-dimensional physical harmonic vibration inertial guidance technology

Also known as: Friend-I External Physical Vibration Lithecbole
Group 2

Eligibility Criteria

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

You may qualify if:

  • Age of 18-65 years;
  • The diameter of calculus is less than or equal to 15mm;
  • Renal or upper ureteral calculus;
  • There's no urinary tract obstruction below stones, and stones didn't cause complete urinary tract obstruction;
  • Stones are fragmented successfully on single session of ESWL, and the diameter of any of fragments is less than 6mm;
  • Normal renal function,

You may not qualify if:

  • Couldn't tolerate EPVL;
  • Urinary tract anomalies, stricture or obstruction;
  • Calculus in diverticulum;
  • Severe hydronephosis;
  • Combined with acute urinary tract infection;
  • Coagulation abnormalities;
  • Morbid obesity(BMI\>35kg/m2);
  • Patients with ureteral stent;
  • Stones aren't fragment successfully, or the diameter of at least one fragment is more than 6mm ;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsUltrasonic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Guohua Zeng, PH.D and M.D

    The First Affiliated Hospital of Guangzhou Medical

    STUDY CHAIR

Central Study Contacts

Guohua Zeng, PH.D and M.D

CONTACT

+86 13802916676gzgyzgh@vip.tom.com

Zhou Yang

CONTACT

+86 13416129917910074460@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of the Hospital

Study Record Dates

First Submitted

December 4, 2015

First Posted

December 31, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 31, 2015

Record last verified: 2015-08

Locations

CN(1)