NCT02989818

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Endoscopic Submucosal Dissection

Interventions

Type	Name	Description
OTHER	Endoscopic Submucosal Dissection	This intervention is part of the subjects standard of care and is a method to remove the Gastrointestinal lesion.

Timeline

• Start date: 2016-03-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2016-12-12
• Last updated: 2026-04-07

Locations

3 sites across 1 country: United States