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

Purpose

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	Intervention	Phase
Urinary Calculi	Device: Navigator Ureteral Access Sheath	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

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 ]

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. [ Time Frame: at time of intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	176
Study Start Date:	May 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator ureteroscopy with ureteral access sheath	Device: Navigator Ureteral Access Sheath ureteral access sheath
2: No Intervention ureteroscopy without ureteral access sheath

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Upper ureteral (proximal to iliac vessels/iliac crest) calculi;
Renal calculi;
ASA class I or II;
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199524

Contacts


Contact: Linda Nott, RN	519-646-6310	Linda.Nott@sjhc.london.on.ca

Locations


Canada, Alberta
	Edmonton Prostate and Urological Research Centre	Recruiting
	Edmonton, Alberta, Canada, T5H 4B9
	Contact: Kim Kordov, BScN 780-448-2789 kkordov@aburologyinstitute.ca
	Contact: Donna M Weiss, BScN 780-448-2789 DonnaM.Weiss@capitalhealth.ca
	Principal Investigator: Tim A Wollin, MD, FRCSC
	Sub-Investigator: Michael Chetner, MD, FRCSC
	Sub-Investigator: Eric Estey, MD, FRCSC
	Sub-Investigator: Howard Evans, MD, FRCSC
	Sub-Investigator: Michael Hobart, MD, FRCSC

Canada, British Columbia
	The Prostate Centre at Vancouver General Hospital	Recruiting
	Vancouver, British Columbia, Canada, V5Z 3J5
	Contact: Olga Arsovska 604-875-4111 ext 62421 olga.arsovska@ubc.ca
	Principal Investigator: Ryan F Paterson, MD, FRCSC
	Sub-Investigator: Ben H Chew, MD, FRCSC

Canada, Ontario
	Urology Clinic, St. Joseph's Hospital, St. Joseph's Health Care London	Recruiting
	London, Ontario, Canada, N6A 4V2
	Contact: Linda Nott, RN 519-646-6310 Linda.Nott@sjhc.london.on.ca
	Principal Investigator: Hassan Razvi, MD, FRCSC
	Sub-Investigator: John D Denstedt, MD, FRCSC
	Sub-Investigator: Stephen E Pautler, MD, FRCSC
	Centre for Advanced Urological Research at Queen's University	Recruiting
	Kingston, Ontario, Canada, K7L 3J7
	Contact: Laurel E Emerson, RN 613-548-6033 emersonl@kgh.kari.ca
	Contact: Angela M Black, RN 613-549-6666 ext 3848 blacka@kgh.kari.ca
	Sub-Investigator: Darren T Beiko, MD, FRCSC
	Kidney Stone Program at St. Michael's Hospital	Recruiting
	Toronto, Ontario, Canada, M5B 1W8
	Contact: Daniela Ghiculete, MSc 416-864-6060 ext 6344 ghiculeted@smh.toronto.on.ca
	Principal Investigator: Ken Pace, MD, FRCSC
	Sub-Investigator: John Honey, MD, FRCSC

Sponsors and Collaborators

Lawson Health Research Institute

Boston Scientific Corporation

Investigators


Principal Investigator:	Hassan Razvi, MD, FRCSC	Urology, St. Joseph's Hospital, University of Western Ontario

More Information

Responsible Party:	Lawson Health Research Institute ( Dr. Hassan Razvi )
Study ID Numbers:	R-05-002
First Received:	September 13, 2005
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00199524
Health Authority:	Canada: Health Canada

Keywords provided by Lawson Health Research Institute:

ureteroscopy

stone free

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Urinary Calculi

Urologic Diseases

Urolithiasis

Calculi

ClinicalTrials.gov processed this record on October 15, 2008

Sponsors and Collaborators:	Lawson Health Research Institute Boston Scientific Corporation
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00199524