Multi-center Evaluation of the Clinical Utility of ESD in the Western Population
Purpose
The aim of this multi-center study is to prospectively document the clinical utility of ESD.
Condition
- Endoscopic Submucosal Dissection
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Lesion of the Gastrointestinal tract | Investigator will collect prospective data on the Endoscopic Submucosal dissection that is used as part of the subjects standard of care to remove the Gastrointestinal lesion |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- University of Florida
Detailed Description
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.