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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00581178
First Posted: December 27, 2007
Last Update Posted: June 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Litholink
Information provided by (Responsible Party):
Victor Huynh, University of California, Irvine
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation

Resource links provided by NLM:


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

Enrollment: 16
Study Start Date: April 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581178


Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Litholink
Investigators
Principal Investigator: Ralph Clayman, MD University of California, Irvine
  More Information

Responsible Party: Victor Huynh, Urology Account Contact, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00581178     History of Changes
Other Study ID Numbers: 2007-5818
First Submitted: December 19, 2007
First Posted: December 27, 2007
Last Update Posted: June 26, 2013
Last Verified: June 2013

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

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical