Extracorporal Shockwave Lithotripsy Versus Retrograde Int... | NCT01514032

Studies
Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones

NCT01514032

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Jan 20, 2012Estimated

Enrollment

230Estimated

Phase

Not Applicable

Conditions

Kidney Stones

Interventions

Extracorporal shockwave lithotripsy
Retrograde intrarenal surgery

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Feb 2014Estimated

Completion Date

Feb 2014Estimated

First Submitted Date

Jan 16, 2012

First Submission Date that Met QC Criteria

Jan 19, 2012

First Posted Date

Jan 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2012

Last Update Posted Date

Jan 20, 2012Estimated

Description Module

Brief Summary

The purpose of this study is to compare two established modalities for the treatment of kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with stone-extraction). Comparison of the stone-free rates 3month postoperative.

Trial with surgical intervention

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

230Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Extracorporal shockwave lithotripsy	Active Comparator		Procedure: Extracorporal shockwave lithotripsy
Retrograde intrarenal surgery	Active Comparator		Procedure: Retrograde intrarenal surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Extracorporal shockwave lithotripsy	Procedure	Extracorporal shockwave lithotripsy	Extracorporal shockwave lithotripsy

Measure	Description	Time Frame
stonefree-rates 3month after therapy		3 month

Eligibility Module

Eligibility Criteria

Inclusion criteria: - kidneystones requiring treatment up to an maximal size of 15mm (singular or multiple kidneystones with at least one stone with min. 5mm of size)

male and female patients between 18 and 99 years
informed consent signed by patient after explanation of the both treatment-modalities

Exclusion criteria: - age < 18 or > 99

pregnancy
breastfeeding mother
disorders of blood clotting
kidneystones > 15mm
aneurysms of the aorta or renal artery
severe skeletal deformations which hamper one of the treatment modalities
synchronous stones of the ipsilateral ureter
stones which can not visualized which X-ray or sonography

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Damian Weber, MD	Contact	+41 44 2555407		damian.weber@usz.ch
Michael Muentener, MD	Contact	+41 44 2555403		michael.muentener@usz.ch

Overall Officials

Name	Affiliation	Role
01 Studienregister MasterAdmins	UniversitaetsSpital Zuerich	Study Director
Michael Muentener, MD	University Hospital Zurich, Division of urology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Urology	Recruiting	Zurich			Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided