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

NCT00199524 | Terminated Phase 4

• 1 other identifier: R-05-002
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 5

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

Keywords

ureteroscopy; stone free

Outcome Measures

Primary Outcomes (1)

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

  3 months post ureteroscopy

Secondary Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

ureteroscopy with ureteral access sheath

Device: Navigator Ureteral Access Sheath

2

NO INTERVENTION

ureteroscopy without ureteral access sheath

Interventions

Navigator Ureteral Access Sheath DEVICE

ureteral access sheath

Also known as: Navigator Ureteral Access Shealth

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Boston Scientific Corporation: collaborator

Study Sites (5)

Edmonton Prostate and Urological Research Centre

Edmonton, Alberta, T5H 4B9, Canada

Location

The Prostate Centre at Vancouver General Hospital

Vancouver, British Columbia, V5Z 3J5, Canada

Location

Centre for Advanced Urological Research at Queen's University

Kingston, Ontario, M5B 1W8, Canada

Location

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

London, Ontario, N6A 4V2, Canada

Location

Kidney Stone Program at St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hassan Razvi, MD, FRCSC

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: May 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 14, 2009

Record last verified: 2009-10

Locations

CA (5)