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

Gastrointestinal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968552
• Other study ID #: Stents/ERCP
• Status: Completed
• Phase: N/A
• First received: August 28, 2009
• Last updated: October 25, 2016
• Start date: August 2009
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Procedure:
• Self-expandable stent placement via endoscopy
Self-expandable stent placement via endoscopy

Locations

Country	Name	City	State
United States	Shands UF endoscopy Center	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		at the time of stent placement	No