Use of Metal Stents on Benign Esophageal Lesions

This study is currently recruiting participants.
Verified April 2014 by University of Florida
Information provided by (Responsible Party):
University of Florida Identifier:
First received: November 5, 2010
Last updated: April 3, 2014
Last verified: April 2014

The evaluation of using metal stents as medically indicated for the treatment of benign esophageal lesions.

Condition Intervention
Benign Esophageal Lesions
Procedure: Endoscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Clinical Utility of the Endoscopic Placement of Mental Stent for Benign Esophageal Lesions

Resource links provided by NLM:

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Successful stenting of Benign esophageal lesions [ Time Frame: approximately 2-3 hours ] [ Designated as safety issue: No ]
    This is an observational study to determine the effectiveness of stenting benign esophageal lesions with a metal stent.

Estimated Enrollment: 150
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
benign esophageal lesions
All patients who have a benign esophageal lesion where it is medically indicated that they receive a stent.
Procedure: Endoscopy
Endoscopic placement of an esophageal metal stent as per medical indication.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have a medical indication for endoscopic placement of esophageal metal stent and are referred for the porcedure as part of their standard medical care will be considered for the study.


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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01238913

Contact: Peter V Draganov, MD 352-273-9400

United States, Florida
Shands at UF Endoscopy Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Peter Draganov, MD    352-273-9400   
Principal Investigator: Peter Draganov, MD         
Sub-Investigator: Chris Forsmark, MD         
Sub-Investigator: Mihir Wagh, MD         
Sub-Investigator: Shailendra Chauhan, MD         
Sponsors and Collaborators
University of Florida
Principal Investigator: Peter Draganov, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida Identifier: NCT01238913     History of Changes
Other Study ID Numbers: Benign esophageal lesions
Study First Received: November 5, 2010
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board processed this record on April 23, 2014