Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate

October 13, 2009 updated by: Lawson Health Research Institute

A Prospective Randomized Controlled Clinical Trial of the Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate

Patients with upper ureteral or renal stones will be randomized to undergoing ureteroscopy with or without a ureteral access sheath. The sheath is designed to facilitate ureteroscope insertion and re-insertion, thus allowing fragments to be basketed out. Stone free rates at 3 months will be determined between the two groups.

The investigators hypothesize that the use of the ureteral access sheath with ureteroscopy will result in improved stone free rates at 3 months compared to ureteroscopy without use of a sheath.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5H 4B9
        • Edmonton Prostate and Urological Research Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3J5
        • The Prostate Centre at Vancouver General Hospital
    • Ontario
      • Kingston, Ontario, Canada, M5B 1W8
        • Centre for Advanced Urological Research at Queen's University
      • London, Ontario, Canada, N6A 4V2
        • Urology at St. Joseph's Hospital, The University of Western Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Kidney Stone Program at St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Upper ureteral (proximal to iliac vessels/iliac crest) calculi;
  • Renal calculi;
  • Normal renal function;
  • Any stone composition;
  • Single or multiple stones(planned treatment of all stones at this surgery);
  • Age > 18 years;
  • Able and willing to return treatment centre for follow-up visits; AND
  • Signed study consent

Exclusion Criteria:

  • Ureteric calculi distal to the level of the iliac vessels/iliac crest;
  • Failed ureteroscopy for same stone (i.e. has to be the first ureteroscopic procedure for this stone, however a prior failed extracorporeal shockwave lithotripsy (SWL) is acceptable);
  • Bilateral ureteroscopy;
  • If an adjunctive procedure is planned post ureteroscopy (e.g. percutaneous nephrolithotomy, SWL) (i.e. it is known preoperatively that a ureteroscopic procedure will not render the patient stone free and that ancillary procedures will be necessary);
  • If in the investigators opinion, enrollment would be not be appropriate; OR
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
ureteroscopy with ureteral access sheath
Device: Navigator Ureteral Access Sheath
ureteral access sheath
Other Names:
  • Navigator Ureteral Access Shealth
No Intervention: 2
ureteroscopy without ureteral access sheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary end point is the stone free rate at 3 months post ureteroscopy.
Time Frame: 3 months post ureteroscopy
3 months post ureteroscopy

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary end points include operative and surgical factors such as operative time, stone size, stone location, stone composition, patient sex and the presence of a ureteric stent post-op.
Time Frame: at time of intervention
at time of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Hassan Razvi, MD, FRCSC, Urology, St. Joseph's Hospital, The University of Western Ontario

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

October 14, 2009

Last Update Submitted That Met QC Criteria

October 13, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-05-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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