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

NCT ID: NCT00199524

Last Updated: 2009-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2009-05-31

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.

Conditions

Urinary Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

ureteroscopy with ureteral access sheath

Group Type: ACTIVE_COMPARATOR

Navigator Ureteral Access Sheath

Intervention Type: DEVICE

ureteral access sheath

2

ureteroscopy without ureteral access sheath

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Navigator Ureteral Access Sheath

ureteral access sheath

Intervention Type: DEVICE

Other Intervention Names

Navigator Ureteral Access Shealth

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Lawson Health Research Institute

Principal Investigators

Hassan Razvi, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Urology, St. Joseph's Hospital, The University of Western Ontario

Locations

Edmonton Prostate and Urological Research Centre

Edmonton, Alberta, Canada

The Prostate Centre at Vancouver General Hospital

Vancouver, British Columbia, 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

Countries

Canada

Other Identifiers

R-05-002

Identifier Type: -

Identifier Source: org_study_id