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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02989818
Other study ID # IRB201600246
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 2016
Est. completion date January 2026

Study information

Verified date June 2024
Source University of Florida
Contact Peter Draganov, MD
Phone 352-273-9472
Email peter.draganov@medicine.ufl.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Endoscopic Submucosal Dissection
This intervention is part of the subjects standard of care and is a method to remove the Gastrointestinal lesion.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts
United States University of Florida Gainesville Florida
United States Baylor College of Medicine Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of en-bloc resection An Excision of the targeted lesion in a single specimen 3-4 hours
Secondary Rate of R0 resection when all vertical and horizontal margins are negative 3-4 hours
Secondary Rate of R1 resection complete resection with no grossly visible lesion defined by endoscopist but microscopically positive horizontal and /or vertical margins 3-4 hours
Secondary Curative resection this will have the following: R0 resection, Well to moderately differentiated histology, Absence of Lymphovascular invasion, Absence of budding, Absence of invasion beyond superficial submucosa 3-4 hours
Secondary Rate of Adverse events with ESD Early (<48 hours) and late (>48 hours) adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE) 1 month
Secondary Rate of complete remission of neoplasia Absence of a visible lesion and/or absence of the neoplastic lesion on biopsy specimens (histopathology) obtained from the ESD site on follow up evaluations 1 month
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