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Evaluating Ureteral Length Using Computed Tomography (CT) (URO-Y-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01542593
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Ureteral Calculi Hydronephrosis Ureteral Obstruction Device: Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Ureteral Length Measurement by Computed Tomography (CT) to Actual Ureteral Length Measured by Ureteral Catheterization
Study Start Date : February 2012
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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).

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:
  • Cook Urological Inc. open end ureteral catheter 5FR
  • Karl Storz cystoscope 19-22F


Outcome Measures

Primary Outcome Measures :
  1. Agreement between measurement of ureteral length (Centimeters) measured by CT and by ureteral catheterization [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing planned procedure involving ureteroscopy or ureteral stenting
  • Abdominal CT scan performed within 6 months prior to intervention

Exclusion Criteria:

  • Known iodine sensitivity
  • Patients with fever or hemodynamic instability planned for urgent operation
  • Severe immune compromized patients
  • Severe thrombocytopenia < 50,000
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542593


Locations
Israel
Carmel Medical Center
Haifa, Israel, 34362
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Yuval Freifeld, Dr. Carmel Medical Center
More Information

Responsible Party: Yuval Freifeld, Resident , Urology Department, principal investigator, Medical doctor, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01542593     History of Changes
Other Study ID Numbers: CMC-11-0051-CTIL
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Calculi
Hydronephrosis
Ureteral Calculi
Ureterolithiasis
Ureteral Obstruction
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Ureteral Diseases
Urolithiasis
Urinary Calculi