Evaluating Ureteral Length Using Computed Tomography (CT) (URO-Y-2)
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| First Received Date ICMJE | February 16, 2012 | ||||
| Last Updated Date | December 18, 2012 | ||||
| Start Date ICMJE | February 2012 | ||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Agreement between measurement of ureteral length (Centimeters) measured by CT and by ureteral catheterization [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01542593 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluating Ureteral Length Using Computed Tomography (CT) | ||||
| Official Title ICMJE | Evaluation of Ureteral Length Measurement by Computed Tomography (CT) to Actual Ureteral Length Measured by Ureteral Catheterization | ||||
| Brief Summary | Proper selection of ureteral stent length might help in reducing comorbidities associated with ureteral stenting, currently there is no standardized way of measuring ureteral length. Measurement of ureteral length according to Computed Tomography (CT) scan might provide useful information when selecting the length of a ureteral stent. Our aim in this study is to compare ureteral measurements using CT scan and measurement of actual ureteral length measured during ureteral stenting. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR
During a planned procedure involving ureteroscopy or ureteral stenting, after retrograde pyelography and insertion of a safety wire, ureteral catheterization will be performed using Cook Urological Inc. open end ureteral catheter 5FR for the purpose of measuring exact ureteral length. Measurement results will be compared to measurements performed on CT scan (obtained before surgery). Other Names:
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| Study Arm (s) | Experimental: Ureteral catheterization
During a planned procedure involving ureteroscopy or ureteral stenting, ureteral catheterization will be performed for the purpose of measuring exact ureteral length. Measurement results will be compared to measurements performed on CT scan (obtained before surgery). Intervention: Device: Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01542593 | ||||
| Other Study ID Numbers ICMJE | CMC-11-0051-CTIL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Yuval Freifeld, Carmel Medical Center | ||||
| Study Sponsor ICMJE | Carmel Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Carmel Medical Center | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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