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

Urinary Calculi Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00199524
• Other study ID #: R-05-002
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: October 13, 2009
• Start date: May 2005
• Est. completion date: May 2009

Study information

• Verified date: October 2009
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Calculi

Intervention

Device:
• Navigator Ureteral Access Sheath
ureteral access sheath

Locations

Country	Name	City	State
Canada	Edmonton Prostate and Urological Research Centre	Edmonton	Alberta
Canada	Centre for Advanced Urological Research at Queen's University	Kingston	Ontario
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	The Prostate Centre at Vancouver General Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Boston Scientific Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end point is the stone free rate at 3 months post ureteroscopy.		3 months post ureteroscopy	No
Secondary	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	No