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

University of Florida

Status: Enrolling

Conditions: Endoscopic Submucosal Dissection

Treatments: Other: Endoscopic Submucosal Dissection

Study type: Observational

Funder types: Other

Identifiers

NCT02989818

IRB201600246

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Lesion of the Gastrointestinal tract

Description:

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

Treatment:

Other: Endoscopic Submucosal Dissection