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| Sponsors and Collaborators: |
Lawson Health Research Institute 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 |
| Estimated Enrollment: | 176 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Linda Nott, RN | 519-646-6310 | Linda.Nott@sjhc.london.on.ca |
| Canada, Alberta | |||||
| Edmonton Prostate and Urological Research Centre | Recruiting | ||||
| Edmonton, Alberta, Canada, T5H 4B9 | |||||
| Contact: Kim Kordov, BScN 780-448-2789 kkordov@aburologyinstitute.ca | |||||
| Contact: Donna M Weiss, BScN 780-448-2789 DonnaM.Weiss@capitalhealth.ca | |||||
| Principal Investigator: Tim A Wollin, MD, FRCSC | |||||
| Sub-Investigator: Michael Chetner, MD, FRCSC | |||||
| Sub-Investigator: Eric Estey, MD, FRCSC | |||||
| Sub-Investigator: Howard Evans, MD, FRCSC | |||||
| Sub-Investigator: Michael Hobart, MD, FRCSC | |||||
| Canada, British Columbia | |||||
| The Prostate Centre at Vancouver General Hospital | Recruiting | ||||
| Vancouver, British Columbia, Canada, V5Z 3J5 | |||||
| Contact: Olga Arsovska 604-875-4111 ext 62421 olga.arsovska@ubc.ca | |||||
| Principal Investigator: Ryan F Paterson, MD, FRCSC | |||||
| Sub-Investigator: Ben H Chew, MD, FRCSC | |||||
| Canada, Ontario | |||||
| Urology Clinic, St. Joseph's Hospital, St. Joseph's Health Care London | Recruiting | ||||
| London, Ontario, Canada, N6A 4V2 | |||||
| Contact: Linda Nott, RN 519-646-6310 Linda.Nott@sjhc.london.on.ca | |||||
| Principal Investigator: Hassan Razvi, MD, FRCSC | |||||
| Sub-Investigator: John D Denstedt, MD, FRCSC | |||||
| Sub-Investigator: Stephen E Pautler, MD, FRCSC | |||||
| Centre for Advanced Urological Research at Queen's University | Recruiting | ||||
| Kingston, Ontario, Canada, K7L 3J7 | |||||
| Contact: Laurel E Emerson, RN 613-548-6033 emersonl@kgh.kari.ca | |||||
| Contact: Angela M Black, RN 613-549-6666 ext 3848 blacka@kgh.kari.ca | |||||
| Sub-Investigator: Darren T Beiko, MD, FRCSC | |||||
| Kidney Stone Program at St. Michael's Hospital | Recruiting | ||||
| Toronto, Ontario, Canada, M5B 1W8 | |||||
| Contact: Daniela Ghiculete, MSc 416-864-6060 ext 6344 ghiculeted@smh.toronto.on.ca | |||||
| Principal Investigator: Ken Pace, MD, FRCSC | |||||
| Sub-Investigator: John Honey, MD, FRCSC | |||||
| Lawson Health Research Institute |
| Boston Scientific Corporation |
| Principal Investigator: | Hassan Razvi, MD, FRCSC | Urology, St. Joseph's Hospital, University of Western Ontario |
More Information
| Responsible Party: | Lawson Health Research Institute ( Dr. Hassan Razvi ) |
| Study ID Numbers: | R-05-002 |
| First Received: | September 13, 2005 |
| Last Updated: | September 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00199524 |
| Health Authority: | Canada: Health Canada |
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