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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Yuval Freifeld, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01542593
First received: February 16, 2012
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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 Intervention
Ureteral Calculi
Hydronephrosis
Ureteral Obstruction
Device: Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Ureteral Length Measurement by Computed Tomography (CT) to Actual Ureteral Length Measured by Ureteral Catheterization

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Agreement between measurement of ureteral length (Centimeters) measured by CT and by ureteral catheterization [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542593

Contacts
Contact: Yuval Freifeld, Dr. +972-52-3153511 Yuvalfr@clalit.org.il

Locations
Israel
Carmel Medical Center Recruiting
Haifa, Israel, 34362
Contact: Yuval Freifeld, Dr.       Yuvalfr@clalit.org.il   
Principal Investigator: Yuval Freifeld, Dr.         
Sub-Investigator: Avi Stein, Prof.         
Sub-Investigator: Tal May, Dr.         
Sub-Investigator: Alexander Kaplun, Dr.         
Sub-Investigator: Dmitry Goldin, Dr.         
Sub-Investigator: Yoel Metz, Dr.         
Sub-Investigator: Yoram Dekel, Dr.         
Sub-Investigator: Gazi Fares, Dr.         
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Yuval Freifeld, Dr. Carmel Medical Center
  More Information

No publications provided

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
Study First Received: February 16, 2012
Last Updated: November 13, 2013
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on October 23, 2014