Status:
TERMINATED
Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Urinary Calculi
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00199524
Start Date
May 1 2005
End Date
May 1 2009
Last Update
October 14 2009
Active Locations (5)
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1
Edmonton Prostate and Urological Research Centre
Edmonton, Alberta, Canada, T5H 4B9
2
The Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 3J5
3
Centre for Advanced Urological Research at Queen's University
Kingston, Ontario, Canada, M5B 1W8
4
Urology at St. Joseph's Hospital, The University of Western Ontario
London, Ontario, Canada, N6A 4V2