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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00199524
Recruitment Status : Terminated (Enrollment was slower than anticipated.)
First Posted : September 20, 2005
Last Update Posted : October 14, 2009
Boston Scientific Corporation
Information provided by:
Lawson Health Research Institute

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Urinary Calculi Device: Navigator Ureteral Access Sheath Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Clinical Trial of the Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate
Study Start Date : May 2005
Actual Primary Completion Date : March 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Active Comparator: 1
ureteroscopy with ureteral access sheath
Device: Navigator Ureteral Access Sheath
ureteral access sheath
Other Name: Navigator Ureteral Access Shealth

No Intervention: 2
ureteroscopy without ureteral access sheath

Primary Outcome Measures :
  1. The primary end point is the stone free rate at 3 months post ureteroscopy. [ Time Frame: 3 months post ureteroscopy ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00199524

Canada, Alberta
Edmonton Prostate and Urological Research Centre
Edmonton, Alberta, Canada, T5H 4B9
Canada, British Columbia
The Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 3J5
Canada, Ontario
Centre for Advanced Urological Research at Queen's University
Kingston, Ontario, Canada, M5B 1W8
Urology at St. Joseph's Hospital, The University of Western Ontario
London, Ontario, Canada, N6A 4V2
Kidney Stone Program at St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
Lawson Health Research Institute
Boston Scientific Corporation
Principal Investigator: Hassan Razvi, MD, FRCSC Urology, St. Joseph's Hospital, The University of Western Ontario

Responsible Party: Dr. Hassan Razvi, Lawson Health Research Institute Identifier: NCT00199524     History of Changes
Other Study ID Numbers: R-05-002
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009

Keywords provided by Lawson Health Research Institute:
stone free

Additional relevant MeSH terms:
Urinary Calculi
Pathological Conditions, Anatomical
Urologic Diseases