Back to resultsUse of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate
Primary Purpose
Urinary Calculi
Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Navigator Ureteral Access Sheath
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Calculi focused on measuring ureteroscopy, stone free
Eligibility Criteria
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
Sites / Locations
- Edmonton Prostate and Urological Research Centre
- The Prostate Centre at Vancouver General Hospital
- Centre for Advanced Urological Research at Queen's University
- Urology at St. Joseph's Hospital, The University of Western Ontario
- Kidney Stone Program at St. Michael's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
ureteroscopy with ureteral access sheath
ureteroscopy without ureteral access sheath
Outcomes
Primary Outcome Measures
The primary end point is the stone free rate at 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.
Full Information
NCT ID
NCT00199524
First Posted
September 13, 2005
Last Updated
October 13, 2009
Sponsor
Lawson Health Research Institute
Collaborators
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00199524
Brief Title
Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate
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 Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Terminated
Why Stopped
Enrollment was slower than anticipated.
Study Start Date
May 2005 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Calculi
Keywords
ureteroscopy, stone free
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
ureteroscopy with ureteral access sheath
Arm Title
2
Arm Type
No Intervention
Arm Description
ureteroscopy without ureteral access sheath
Intervention Type
Device
Intervention Name(s)
Navigator Ureteral Access Sheath
Other Intervention Name(s)
Navigator Ureteral Access Shealth
Intervention Description
ureteral access sheath
Primary Outcome Measure Information:
Title
The primary end point is the stone free rate at 3 months post ureteroscopy.
Time Frame
3 months post ureteroscopy
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Razvi, MD, FRCSC
Organizational Affiliation
Urology, St. Joseph's Hospital, The University of Western Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edmonton Prostate and Urological Research Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 4B9
Country
Canada
Facility Name
The Prostate Centre at Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3J5
Country
Canada
Facility Name
Centre for Advanced Urological Research at Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Urology at St. Joseph's Hospital, The University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Kidney Stone Program at St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
12. IPD Sharing Statement
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Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate
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