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

This study has been terminated.
(Enrollment was slower than anticipated.)
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00199524
First received: September 13, 2005
Last updated: October 13, 2009
Last verified: October 2009

September 13, 2005
October 13, 2009
May 2005
March 2009   (final data collection date for primary outcome measure)
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 ]
The primary end point is the stone free rate at 3 months post ureteroscopy.
Complete list of historical versions of study NCT00199524 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate
A Prospective Randomized Controlled Clinical Trial of the Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Urinary Calculi
Device: Navigator Ureteral Access Sheath
ureteral access sheath
Other Name: Navigator Ureteral Access Shealth
  • Active Comparator: 1
    ureteroscopy with ureteral access sheath
    Intervention: Device: Navigator Ureteral Access Sheath
  • No Intervention: 2
    ureteroscopy without ureteral access sheath
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
44
May 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00199524
R-05-002
No
Dr. Hassan Razvi, Lawson Health Research Institute
Lawson Health Research Institute
Boston Scientific Corporation
Principal Investigator: Hassan Razvi, MD, FRCSC Urology, St. Joseph's Hospital, The University of Western Ontario
Lawson Health Research Institute
October 2009

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