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

Primary Purpose

Ureteral Calculi, Hydronephrosis, Ureteral Obstruction

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ureteral Calculi

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carmel Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ureteral catheterization

Arm Description

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).

Outcomes

Primary Outcome Measures

Agreement between measurement of ureteral length (Centimeters) measured by CT and by ureteral catheterization

Secondary Outcome Measures

Full Information

First Posted
February 16, 2012
Last Updated
April 29, 2015
Sponsor
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01542593
Brief Title
Evaluating Ureteral Length Using Computed Tomography (CT)
Acronym
URO-Y-2
Official Title
Evaluation of Ureteral Length Measurement by Computed Tomography (CT) to Actual Ureteral Length Measured by Ureteral Catheterization
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carmel Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Calculi, Hydronephrosis, Ureteral Obstruction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ureteral catheterization
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR
Other Intervention Name(s)
Cook Urological Inc. open end ureteral catheter 5FR, Karl Storz cystoscope 19-22F
Intervention Description
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).
Primary Outcome Measure Information:
Title
Agreement between measurement of ureteral length (Centimeters) measured by CT and by ureteral catheterization
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuval Freifeld, Dr.
Organizational Affiliation
Carmel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel

12. IPD Sharing Statement

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Evaluating Ureteral Length Using Computed Tomography (CT)

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