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Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation
This study is currently recruiting participants.
Verified by University of California, Irvine, June 2008
Sponsors and Collaborators: University of California, Irvine
Litholink
Information provided by: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00581178
  Purpose

Ureteral stent placement is one of the most common procedures performed within urology. The stents are generally placed for relief of obstruction or to prevent obstruction following a urological procedure. Most patients with ureteral stents will eventually form stent encrustations. However, patients form these encrustations at dramatically different degrees and rates ranging from no encrustation at 1 year of stenting to severe encrustation in just a few weeks. The purpose of this study is to determine if the degree of encrustation on a stent for any given patient can be predicted based on 24 hour urine parameters prior to stent placement, with the stent in place and after stent removal.

Patients who will be receiving stents for other urological reasons will have a 24 hour urine sample collected before stent placement, while the stent is in place and after the stent has been removed. The parameters examined in the 24 hour urine collected will then be compared to the amount of encrustation there is on the stent to see if there is any correlation between the two.


Condition
Kidney Stones

U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective

Further study details as provided by University of California, Irvine:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 30
Study Start Date: April 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients who will undergo surgery where a ureteral stent will likely be placed will be offered enrollment into this study.

Criteria

Inclusion Criteria:

  • Patient at UCI
  • Scheduled to undergo surgery (standard of care) where ureteral stent will be placed

Exclusion Criteria:

  • minors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581178

Contacts
Contact: Rosanne Santos 714-456-8176 rtsantos@uci.edu

Locations
United States, California
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92868
Principal Investigator: Ralph Clayman, MD            
Sub-Investigator: Elspeth McDougall, MD            
Sub-Investigator: Geoffrey Box, MD            
Sub-Investigator: Michael Louie, MD            
Sponsors and Collaborators
University of California, Irvine
Litholink
Investigators
Principal Investigator: Ralph Clayman, MD University of California, Irvine
  More Information

Responsible Party: University of California, Irvine ( Ralph V. Clayman, MD )
Study ID Numbers: 2007-5818
Study First Received: December 19, 2007
Last Updated: June 16, 2008
ClinicalTrials.gov Identifier: NCT00581178  
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Ureteral Stent
Kidney Stones

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Urolithiasis
Kidney Diseases
Calculi
Nephrolithiasis
Kidney Calculi

ClinicalTrials.gov processed this record on January 13, 2009