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Enrollment was slower than anticipated.
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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | ureteroscopy with ureteral access sheath |
|
| 2 | No Intervention | ureteroscopy without ureteral access sheath |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigator Ureteral Access Sheath | Device | ureteral access sheath |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary end point is the stone free rate at 3 months post ureteroscopy. | 3 months post ureteroscopy |
| Measure | Description | 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. | at time of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Razvi, MD, FRCSC | Urology, St. Joseph's Hospital, The University of Western Ontario | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edmonton Prostate and Urological Research Centre | Edmonton | Alberta | T5H 4B9 | Canada | ||
| The Prostate Centre at Vancouver General Hospital |
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| ID | Term |
|---|---|
| D014545 | Urinary Calculi |
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Vancouver |
| British Columbia |
| V5Z 3J5 |
| Canada |
| Centre for Advanced Urological Research at Queen's University | Kingston | Ontario | M5B 1W8 | Canada |
| Urology at St. Joseph's Hospital, The University of Western Ontario | London | Ontario | N6A 4V2 | Canada |
| Kidney Stone Program at St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |