Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation
1 other identifier
observational
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2007
CompletedFirst Posted
Study publicly available on registry
December 27, 2007
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJune 26, 2013
June 1, 2013
3.7 years
December 19, 2007
June 24, 2013
Conditions
Keywords
Eligibility Criteria
All patients who will undergo surgery where a ureteral stent will likely be placed will be offered enrollment into this study.
You may qualify if:
- Patient at UCI
- Scheduled to undergo surgery (standard of care) where ureteral stent will be placed
You may not qualify if:
- minors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Irvine Medical Center
Orange, California, 92868, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph Clayman, MD
University of California, Irvine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Urology Account Contact
Study Record Dates
First Submitted
December 19, 2007
First Posted
December 27, 2007
Study Start
April 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
June 26, 2013
Record last verified: 2013-06