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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

October 13, 2009

Start Date ^ICMJE

May 2005

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00199524 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Urinary Calculi

Intervention ^ICMJE

Device: Navigator Ureteral Access Sheath

Study Arms / Comparison Groups

Active Comparator: ureteroscopy with ureteral access sheath
No Intervention: ureteroscopy without ureteral access sheath

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

May 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00199524

Responsible Party

Dr. Hassan Razvi, Lawson Health Research Institute

Study ID Numbers ^ICMJE

R-05-002

Study Sponsor ^ICMJE

Lawson Health Research Institute

Collaborators ^ICMJE

Boston Scientific Corporation

Investigators ^ICMJE

Principal Investigator:

Hassan Razvi, MD, FRCSC

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

Information Provided By

Lawson Health Research Institute

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP