Multi-center Evaluation of the Clinical Utility of ESD in the Western Population



Status:Recruiting
Healthy:No
Age Range:18 - 100
Updated:12/2/2018
Start Date:March 2016
End Date:January 2020
Contact:Peter Draganov, MD
Email:peter.draganov@medicine.ufl.edu
Phone:352-273-9472

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Multi-center Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in the Western Population

The aim of this multi-center study is to prospectively document the clinical utility of ESD.

Multi-center prospective data recording study. All patients will receive standard medical
care and no experimental interventions will be performed.

All patients scheduled to undergo ESD at the University of Florida and participating centers
as medically indicated will be considered for the study. Patients in whom ESD is considered
as part of their standard medical care will be offered to participate in this study. The
physician performing the procedure will also discuss the study with the subjects. If the
patient agrees to participate, he or she will be given the informed consent form and allowed
enough time to read it. Opportunity to ask questions will be provided. If the patient agrees
to participate, he or she will sign the consent form and a copy will be provided. Data will
be prospectively recorded according to the data collection form. ESD will be performed as
medically indicated. The investigators from each respective center on this project will also
be in charge of the medical care of the patients enrolled in the study. Follow-up will be
carried out as medically indicated and no additional studies or clinic visits will be needed
specifically for the purpose of this study.

Inclusion Criteria:

- a. Age 18 years or older.

- b. Scheduled to undergo ESD as part of their standard of care.

Exclusion Criteria:

- a. Any contraindication to performing endoscopy.

- b. Participation in another research protocol that could interfere or influence the
outcome measures of the present study.

- c. Patient is unable/unwilling to provide informed consent.
We found this trial at
2
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Peter Draganov, MD
Phone: 352-273-9472
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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