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The StoneBreakerTM Trial

This study has been completed.
Sponsor:
Collaborators:
VGH and UBC Hospital Foundation
Vancouver Coastal Health
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00677196
First received: May 12, 2008
Last updated: September 23, 2010
Last verified: September 2010
  Purpose

The purpose of this study is to compare the LMA StoneBreakerTM to the current standard of pneumatic lithotripsy, the Swiss LithoClastR, during percutaneous nephrolithotripsy (PNL).


Condition Intervention Phase
Percutaneous Nephrolithotripsy
Device: The stonebreaker arm (LMA Stonebreaker)
Device: Pneumatic Lithotripsy (Swiss LithoClastR)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Canadian StoneBreakerTM Trial: A Randomized, Multicentre Trial Comparing The LMA StoneBreakerTM and the Swiss LithoClastR During Percutaneous Nephrolithotripsy.

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Time to complete fragmentation of renal calculi treated via PNL [ Time Frame: During surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to removal of large fragments using graspers & time required with US to remove small fragments/dust [ Time Frame: During surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
The LMA StoneBreakerTM
Device: The stonebreaker arm (LMA Stonebreaker)
The interventional device name is the LMA Stonebreaker pneumatic handheld lithotriptor.
Active Comparator: 2
Pneumatic Lithotripsy
Device: Pneumatic Lithotripsy (Swiss LithoClastR)
Pneumatic lithotripsy, the Swiss LithoClastR during percutaneous nephrolithotripsy (PNL)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients over the age of 18 undergoing PNL
  • Previously untreated renal stones
  • Patients with 3 or less individual renal calculi, accessible with a rigid nephroscope
  • Stones must be at least >225mm2 area on KUB
  • Patient must have a CT scan prior to treatment

Exclusion Criteria:

  • Patients with an active contraindication for PNL (pregnancy, uncorrected coagulopathy, active urinary infection, contrast allergy)
  • Partial staghorn calculi
  • Complete staghorn calculi
  • Stones in calyceal diverticulum
  • Cases requiring multiple tracts
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677196

Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
VGH and UBC Hospital Foundation
Vancouver Coastal Health
Investigators
Principal Investigator: Ben Chew, MD, FRCSC University of British Columbia
Study Director: R. Paterson, MD University of British Columbia
Study Director: J. Wright, MD University of British Columbia
Study Director: J. Teichman, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Ben Chew, University of British Columbia
ClinicalTrials.gov Identifier: NCT00677196     History of Changes
Other Study ID Numbers: H07-01887
Study First Received: May 12, 2008
Last Updated: September 23, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
PNL
Lithoclast
Stonebreaker
efficiency stone fragmentation

ClinicalTrials.gov processed this record on November 25, 2014