Actively Recruiting

Age: 18Years - 100Years
All Genders
ID02989818

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

Led by University of Florida · Updated on 2026-04-07

300

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to document the clinical usefulness of Endoscopic Submucosal Dissection (ESD) in patients from Western populations. The study is observational and involves multiple centers, focusing on patients who are already scheduled to undergo ESD as part of their regular medical care. The goal is to collect data prospectively to better understand the procedure's application in removing gastrointestinal lesions. Participants will receive standard medical care without any experimental treatments. ESD will be performed as medically indicated by their physicians, and the study will record data on the procedure and its outcomes. There are no additional interventions or clinic visits required specifically for the study, and follow-up care will continue as usual. During the study, researchers will collect data on the effectiveness and safety of ESD, including measures like the rate of complete lesion removal and adverse events within one month. The primary outcome is the rate of en-bloc resection, with additional outcomes including curative resection and remission rates. The involvement period varies with each participant's treatment and follow-up schedule, with data collection occurring during and after the procedure as part of standard care.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Scheduled to undergo Endoscopic Submucosal Dissection (ESD) as part of standard medical care
Not Eligible

You will not qualify if you...

  • Any contraindication to performing endoscopy
  • Participation in another research protocol that could interfere or influence the outcome measures of this study
  • Unable or unwilling to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Procedure lasting 3 to 4 hours

Participants undergo Endoscopic Submucosal Dissection (ESD) as part of their standard medical care to remove gastrointestinal lesions.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 1 month or as medically indicated

Participants are observed during follow-up visits carried out as medically indicated without any additional study-specific visits.

Trial Site Locations

Total: 3 locations

1

University of Florida

Gainesville, Florida, United States, 32610

Actively Recruiting

2

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

3

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

P

Peter Draganov, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Safety and feasibility of same-day discharge after endoscopic submucosal dissection: a Western multicenter prospective cohort study.

William King, Peter Draganov, V Subhash Gorrepati...

https://pubmed.ncbi.nlm.nih.gov/36731578