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

NCT ID: NCT01514032

Last Updated: 2012-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-02-28

Brief Summary

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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

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Conditions

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Kidney Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Extracorporal shockwave lithotripsy

Group Type ACTIVE_COMPARATOR

Extracorporal shockwave lithotripsy

Intervention Type PROCEDURE

Extracorporal shockwave lithotripsy

Retrograde intrarenal surgery

Group Type ACTIVE_COMPARATOR

Retrograde intrarenal surgery

Intervention Type PROCEDURE

Retrograde intrarenal surgery

Interventions

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Extracorporal shockwave lithotripsy

Extracorporal shockwave lithotripsy

Intervention Type PROCEDURE

Retrograde intrarenal surgery

Retrograde intrarenal surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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01 Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Michael Muentener, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of urology

Locations

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University Hospital Zurich, Urology

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Damian Weber, MD

Role: CONTACT

+41 44 2555407

Michael Muentener, MD

Role: CONTACT

+41 44 2555403

Other Identifiers

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TOP-Stone

Identifier Type: -

Identifier Source: org_study_id

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