Use of Metal Stents on Benign Esophageal Lesions

September 29, 2015 updated by: University of Florida

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
approximately 2-3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

November 5, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (ESTIMATE)

November 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 29, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Benign esophageal lesions

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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