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

Phase 4

Terminated

• Conditions: Urinary Calculi
• Interventions: Device: Navigator Ureteral Access Sheath

• Registration Number: NCT00199524
• Lead Sponsor: Lawson Health Research Institute

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

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2009-03
• Study Completion: 2009-05
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-13
• Last Update Posted: 2009-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Navigator Ureteral Access Sheath	ureteroscopy with ureteral access sheath

Primary Outcome Measures

Name	Time	Method
The primary end point is the stone free rate at 3 months post ureteroscopy.	3 months post ureteroscopy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Edmonton Prostate and Urological Research Centre; 🇨🇦 Edmonton, Alberta, Canada

Centre for Advanced Urological Research at Queen's University; 🇨🇦 Kingston, Ontario, Canada

The Prostate Centre at Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Urology at St. Joseph's Hospital, The University of Western Ontario; 🇨🇦 London, Ontario, Canada

Kidney Stone Program at St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada