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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00968552
First received: August 28, 2009
Last updated: April 3, 2014
Last verified: April 2014
  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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: August 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968552

Locations
United States, Florida
Shands UF endoscopy Center Recruiting
Gainesville, Florida, United States, 32610
Contact: Pater V Draganov, MD    352-392-2877    peter.draganov@medicine.ufl.edu   
Principal Investigator: Peter V. Draganov, MD         
Sub-Investigator: Chris Forsmark, MD         
Sub-Investigator: Mihir Wagh, MD         
Sub-Investigator: Shailendra Chauhan, MD         
Sponsors and Collaborators
University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00968552     History of Changes
Other Study ID Numbers: Stents/ERCP
Study First Received: August 28, 2009
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014