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

Sponsor
Carmel Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01542593
Collaborator
(none)
53
Enrollment
1
Location
1
Arm
36.9
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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 Phase
  • Device: Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
N/A
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 :
Feb 1, 2012
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

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 [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Carmel Medical Center Haifa Israel 34362

    Sponsors and Collaborators

    • Carmel Medical Center

    Investigators

    • Principal Investigator: Yuval Freifeld, Dr., Carmel Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuval Freifeld, Resident , Urology Department, principal investigator, Medical doctor, Carmel Medical Center
    ClinicalTrials.gov Identifier:
    NCT01542593
    Other Study ID Numbers:
    • CMC-11-0051-CTIL
    First Posted:
    Mar 2, 2012
    Last Update Posted:
    Apr 30, 2015
    Last Verified:
    Apr 1, 2015
    Additional relevant MeSH terms:
    Hydronephrosis
    Ureteral Calculi
    Ureterolithiasis
    Ureteral Obstruction
    Calculi

    Study Results

    No Results Posted as of Apr 30, 2015