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

This study is currently recruiting participants.
Study NCT00199524.   Last updated on September 17, 2008.   Information provided by Lawson Health Research Institute

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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.

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:

  • Upper ureteral (proximal to iliac vessels/iliac crest) calculi;
  • Renal calculi;
  • ASA class I or II;
  • 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Linda Nott, RN     519-646-6310     Linda.Nott@sjhc.london.on.ca    
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 
Principal Investigator:     Hassan Razvi, MD, FRCSC     Urology, St. Joseph's Hospital, University of Western Ontario    
Information Provided By Lawson Health Research Institute
Verification Date September 2008
First Received Date  September 13, 2005
Last Updated Date September 17, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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