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

This study has been terminated.

( Enrollment was slower than anticipated. )

First Received: September 13, 2005 Last Updated: October 13, 2009 History of Changes

Sponsor:	Lawson Health Research Institute
Collaborator:	Boston Scientific Corporation
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00199524

Purpose

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	Intervention	Phase
Urinary Calculi	Device: Navigator Ureteral Access Sheath	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

The primary end point is the stone free rate at 3 months post ureteroscopy. [ Time Frame: 3 months post ureteroscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	May 2005
Study Completion Date:	May 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator ureteroscopy with ureteral access sheath	Device: Navigator Ureteral Access Sheath ureteral access sheath
2: No Intervention ureteroscopy without ureteral access sheath

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199524

Locations

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

Investigators

Principal Investigator:

Hassan Razvi, MD, FRCSC

Urology, St. Joseph's Hospital, The University of Western Ontario

More Information

No publications provided

Responsible Party:	Lawson Health Research Institute ( Dr. Hassan Razvi )
Study ID Numbers:	R-05-002
Study First Received:	September 13, 2005
Last Updated:	October 13, 2009
ClinicalTrials.gov Identifier:	NCT00199524 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Lawson Health Research Institute:

ureteroscopy
stone free

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Urolithiasis
Calculi

ClinicalTrials.gov processed this record on November 27, 2009