Use of Metal Stents on Benign Esophageal Lesions

Benign Esophageal Lesions Clinical Trial

Official title:

Prospective Evaluation of the Clinical Utility of the Endoscopic Placement of Mental Stent for Benign Esophageal Lesions

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01238913
• Other study ID #: Benign esophageal lesions
• Status: Withdrawn
• Phase: N/A
• First received: November 5, 2010
• Last updated: September 29, 2015
• Start date: September 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• 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 evaluation of using metal stents as medically indicated for the treatment of benign esophageal lesions.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is 18 years or older

2. Subject has medical indication to undergo endoscopic placement of esophageal metal stent

3. Subject must be able to give informed consent

Exclusion Criteria:

1. Any contraindications for endoscopic placement of esophageal metal stent

2. The subject is unable to give informed consent.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Benign Esophageal Lesions

Intervention

Procedure:
• Endoscopy
Endoscopic placement of an esophageal metal stent as per medical indication.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful stenting of Benign esophageal lesions	This is an observational study to determine the effectiveness of stenting benign esophageal lesions with a metal stent.	approximately 2-3 hours	No