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| Descriptive Information Fields | |||||
| Brief Title † | Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate | ||||
| 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 | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | 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 Measure † | 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 ] | ||||
| Condition † | Urinary Calculi | ||||
| Intervention † | Device: Navigator Ureteral Access Sheath | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 176 | ||||
| Start Date † | May 2005 | ||||
| Completion Date | December 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | Canada | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00199524 | ||||
| Organization ID | R-05-002 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Lawson Health Research Institute | ||||
| Collaborators †† | Boston Scientific Corporation | ||||
| Investigators † |
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| Information Provided By | Lawson Health Research Institute | ||||
| Verification Date | September 2008 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | September 17, 2008 | ||||