Evaluating Ureteral Length Using Computed Tomography (CT)

Hydronephrosis Clinical Trial

— URO-Y-2  

Official title:

Evaluation of Ureteral Length Measurement by Computed Tomography (CT) to Actual Ureteral Length Measured by Ureteral Catheterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542593
• Other study ID #: CMC-11-0051-CTIL
• Status: Completed
• Phase: N/A
• First received: February 16, 2012
• Last updated: April 29, 2015
• Start date: February 2012
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hydronephrosis
• Ureteral Calculi
• Ureteral Obstruction
• Ureterolithiasis

Intervention

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).

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between measurement of ureteral length (Centimeters) measured by CT and by ureteral catheterization		1 year	No