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Use of Metal Stents on Benign Esophageal Lesions

This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01238913
First received: November 5, 2010
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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 esohageal lesions with a metal stent.


Estimated Enrollment: 150
Study Start Date: August 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (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.

  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT01238913

Contacts
Contact: Peter V Draganov, MD 352-273-9400 peter.draganov@medicine.ufl.edu

Locations
United States, Florida
Shands at UF Endoscopy Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Peter Draganov, MD     352-273-9400     peter.draganov@medicine.ufl.edu    
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
Investigators
Principal Investigator: Peter Draganov, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01238913     History of Changes
Other Study ID Numbers: Benign esophageal lesions
Study First Received: November 5, 2010
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013