Expired Study
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Orange, California 92868


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.


Criteria:

Inclusion Criteria: - Patient at UCI - Scheduled to undergo surgery (standard of care) where ureteral stent will be placed Exclusion Criteria: - minors


Study is Available At:


Original ID:

2007-5818


NCT ID:

NCT00581178


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Irvine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

16


Enrollment Type:

Actual


Overall Contact Information

Official Name:Ralph Clayman, MD
Principal Investigator
University of California, Irvine

Study Dates

Start Date:April 2008
Completion Date:December 2011
Completion Type:Actual
Primary Completion Date:December 2011
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 24, 2013
First Received Date:December 19, 2007

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Irvine
Agency Class:Other
Agency Type:Collaborator
Agency Name:Litholink

Samples and Retentions

Study Population: All patients who will undergo surgery where a ureteral stent will likely be placed will be offered enrollment into this study.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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