Use of Metal Stents on Benign Esophageal Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01238913
Recruitment Status : Withdrawn (No one met the inclusion/exclusion criteria)
First Posted : November 11, 2010
Last Update Posted : October 1, 2015
Information provided by (Responsible Party):
University of Florida

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

Condition or disease Intervention/treatment
Benign Esophageal Lesions Procedure: Endoscopy

Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : September 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Successful stenting of Benign esophageal lesions [ Time Frame: approximately 2-3 hours ]
    This is an observational study to determine the effectiveness of stenting benign esophageal lesions with a metal stent.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01238913

Sponsors and Collaborators
University of Florida
Principal Investigator: Peter Draganov, MD University of Florida

Responsible Party: University of Florida Identifier: NCT01238913     History of Changes
Other Study ID Numbers: Benign esophageal lesions
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015