Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation

NCT ID: NCT00581178

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-12-31

Brief Summary

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.

Conditions

Kidney Stones

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• minors

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Labcorp Corporation of America Holdings, Inc

INDUSTRY

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Victor Huynh

Urology Account Contact

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ralph Clayman, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine Medical Center

Orange, California, United States

Countries

United States

Other Identifiers

2007-5818

Identifier Type: -

Identifier Source: org_study_id