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Prospective Evaluation of the Clinical Utility of Endoscopically Placed Self-expandable Stents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00968552
First Posted: August 31, 2009
Last Update Posted: October 27, 2016
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.
Information provided by (Responsible Party):
University of Florida
  Purpose
The investigators' believe that it is important to medical practice to obtain information on how expandable metal stents work in a large group of patients who have metal stents placed in the gastrointestinal system. The purpose of this research study is to collect information on the stent placement in our facility and how the patients responded to the stent placement.

Condition Intervention
Gastrointestinal Diseases Procedure: Self-expandable stent placement via endoscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Clinical Utility of Endoscopically Placed Self-expandable Stents

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • The purpose of this research study is to collect information on the stent placement in our facility and how the patients responded to the stent placement. [ Time Frame: at the time of stent placement ]

Enrollment: 23
Study Start Date: August 2009
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients undergoing stent placement
Patients who are scheduled to undergo stent placement via endoscopy as part of their routine medical care.
Procedure: Self-expandable stent placement via endoscopy
Self-expandable stent placement via endoscopy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Age 18 or older
Criteria

Inclusion Criteria:

  1. Age 18 years or older.
  2. Scheduled to undergo endoscopy with placement of self-expanding stent at the University of Florida, Gainesville, FL.
  3. Subject must be able to give informed consent.

Exclusion Criteria:

  1. Any contraindication to performing endoscopy.
  2. Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
  3. The subject is unable/unwilling to give informed consent.
  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): NCT00968552


Locations
United States, Florida
Shands UF endoscopy Center
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00968552     History of Changes
Other Study ID Numbers: Stents/ERCP
First Submitted: August 28, 2009
First Posted: August 31, 2009
Last Update Posted: October 27, 2016
Last Verified: October 2016

Keywords provided by University of Florida:
Any Gastrointestinal problem that would require an endoscopically placed stent

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases