NCT00677196

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 27, 2010

Status Verified

September 1, 2010

Enrollment Period

2.6 years

First QC Date

May 12, 2008

Last Update Submit

September 23, 2010

Conditions

Percutaneous Nephrolithotripsy

Keywords

PNLLithoclastStonebreakerefficiency stone fragmentation

Outcome Measures

Primary Outcomes (1)

  • Time to complete fragmentation of renal calculi treated via PNL

    During surgery

Secondary Outcomes (1)

  • Time to removal of large fragments using graspers & time required with US to remove small fragments/dust

    During surgery

Study Arms (2)

1

ACTIVE COMPARATOR

The LMA StoneBreakerTM

Device: The stonebreaker arm (LMA Stonebreaker)

2

ACTIVE COMPARATOR

Pneumatic Lithotripsy

Device: Pneumatic Lithotripsy (Swiss LithoClastR)

Interventions

The stonebreaker arm (LMA Stonebreaker)DEVICE

The interventional device name is the LMA Stonebreaker pneumatic handheld lithotriptor.

1
Pneumatic Lithotripsy (Swiss LithoClastR)DEVICE

Pneumatic lithotripsy, the Swiss LithoClastR during percutaneous nephrolithotripsy (PNL)

2

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Study Officials

  • Ben Chew, MD, FRCSC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2008

First Posted

May 14, 2008

Study Start

February 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 27, 2010

Record last verified: 2010-09

Locations

CA(1)