Back to resultsUreteroscopy With and Without Safety Guidewire
Primary Purpose
Urolithiasis
Status
Withdrawn
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Ureteroscopy with and without safety guidewire
Sponsored by
About this trial
This is an interventional treatment trial for Urolithiasis focused on measuring Ureteroscopy
Eligibility Criteria
Inclusion Criteria:
- Patients with urolithiasis planned for ureterorenoscopic treatment
Sites / Locations
- Helse Bergen HF, Haukeland University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
B - without SGW
A - with SGW
Arm Description
Ureteroscopy without SGW in place.
Ureteroscopy with SGW in place.
Outcomes
Primary Outcome Measures
Stone free-rate
Secondary Outcome Measures
Hospital stay
Complication rate
Operating time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01117688
Brief Title
Ureteroscopy With and Without Safety Guidewire
Official Title
Ureteroscopy With and Without Safety Guidewire:. A Prospective, Randomized Study of the Results of Endoscopic Treatment of Urolithiasis.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn. Not enough time to go through with the study.
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Helse-Bergen HF
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the impact of a safety guidewire (SGW) on the results of ureteroscopy for urolithiasis.
Study hypothesis: Routine use of SGW has no impact on the results of ureteroscopic treatment of urolithiasis.
Detailed Description
The use of SGW is generally recommended at any ureteroscopic procedure in order to facilitate the introduction of the endoscope and to secure placement of internal tubes for drainage of urine after the procedure.
However, SGW may be an obstacle to efficient disintegration and retraction of calculi in the narrow ureter.
The intention of this study is to compare the results of endoscopic stone treatment with and without the use of SGW.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
Ureteroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B - without SGW
Arm Type
Active Comparator
Arm Description
Ureteroscopy without SGW in place.
Arm Title
A - with SGW
Arm Type
Active Comparator
Arm Description
Ureteroscopy with SGW in place.
Intervention Type
Procedure
Intervention Name(s)
Ureteroscopy with and without safety guidewire
Intervention Description
In study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed without SGW.
Primary Outcome Measure Information:
Title
Stone free-rate
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
Hospital stay
Time Frame
Up to 1 week after the operation
Title
Complication rate
Time Frame
Until 3 months after the procedure
Title
Operating time
Time Frame
Up to 1 day after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with urolithiasis planned for ureterorenoscopic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øyvind Ulvik, MD
Organizational Affiliation
Helse Bergen HF, Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helse Bergen HF, Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
12. IPD Sharing Statement
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Ureteroscopy With and Without Safety Guidewire
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