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

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT00199524

Collaborator

Boston Scientific Corporation (Industry)

Enrollment

Locations

Arms

Duration (Months)

8.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Calculi	Device: Navigator Ureteral Access Sheath	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

May 1, 2005

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 ureteroscopy with ureteral access sheath	Device: Navigator Ureteral Access Sheath ureteral access sheath Other Names: Navigator Ureteral Access Shealth
No Intervention: 2 ureteroscopy without ureteral access sheath

Arm

Intervention/Treatment

Active Comparator: 1

ureteroscopy with ureteral access sheath

Device: Navigator Ureteral Access Sheath

ureteral access sheath

Other Names:

Navigator Ureteral Access Shealth

No Intervention: 2

ureteroscopy without ureteral access sheath

Outcome Measures

Primary Outcome Measures

The primary end point is the stone free rate at 3 months post ureteroscopy. [3 months post ureteroscopy]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edmonton Prostate and Urological Research Centre	Edmonton	Alberta	Canada	T5H 4B9
2	The Prostate Centre at Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 3J5
3	Centre for Advanced Urological Research at Queen's University	Kingston	Ontario	Canada	M5B 1W8
4	Urology at St. Joseph's Hospital, The University of Western Ontario	London	Ontario	Canada	N6A 4V2
5	Kidney Stone Program at St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8