Narrow Versus Wide Focal Zones for Shock Wave Lithotripsy of Renal Calculi

Summary

Shockwave lithotripsy (SWL) is a safe, non-invasive treatment for renal calculi. During SWL energy is focused on in order to break kidney stones and this energy can be varied in size from a narrow (or small) focal zone to a wide (or large) focal zone. This is a multi-centered, randomized study comparing the single treatment success rates of narrow and wide focal zones during SWL.

Conditions

• Kidney Stones

Interventions

PROCEDURE

SWL: Shock Wave Lithotripsy Intervention

Shock wave lithotripsy (SWL) is the most common treatment modality for kidney stones. It is a safe and non-invasive treatment performed on patients under intravenous sedation (light anesthesia) on an out-patient basis, whereby shock waves are generated by a source external to the patient's body and are then propagated into the body and focused on a kidney stone. The unique quality of SWL is in its exploitation of shock wave focusing. The Storz lithotripter is an electromagnetic lithotripter with a unique design that allows for a dual focus system with the option of either a narrow (6x28 mm) or wide (9x50 mm) focal zone, depending on the clinical situation. This is the first lithotripter on the market to allow for two different focal zones for shock wave targeting.

Sponsors & Collaborators

• University of Toronto

  collaborator OTHER

• University of Western Ontario, Canada

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• Unity Health Toronto

  lead OTHER

Principal Investigators

• John Honey, MD · St. Michael's Hospital, University of Toronto

• Ken Pace, MD · St. Michael's Hospital, University of Toronto

• Ben Chew, MD · University of British Columbia - Vancouver Coastal Health Research Institute

• Ryan Paterson, MD · University of British Columbia - Vancouver Coastal Health Research Institute

• Hassan Razvi, MD · Western University, Canada

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2016-11-30

Completion

2017-04-30

Countries

• Canada

Study Locations