Evaluating the clinical utility of Endoscopic Submucosal Dissection
Multi-center Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in the Western Population
This study looks at how helpful Endoscopic Submucosal Dissection is for patients who are already scheduled to have the procedure as part of their regular medical care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 3 sites (Gainesville, Florida and 2 other locations) |
| Trial ID | NCT02989818 on ClinicalTrials.gov |
What this trial studies
This multi-center observational study aims to document the clinical utility of Endoscopic Submucosal Dissection (ESD) in patients scheduled for the procedure as part of their standard medical care. Participants will receive standard medical treatment without any experimental interventions. Data will be collected prospectively from multiple centers, including the University of Florida, Massachusetts General Hospital, and Baylor College of Medicine. The study will involve informed consent and follow-up as medically indicated, ensuring that patient care remains the priority.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years or older who are scheduled to undergo ESD as part of their standard medical care.
Not a fit: Patients with contraindications to endoscopy or those participating in conflicting research protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of ESD, potentially improving patient outcomes.
How similar studies have performed: While this study is observational, similar studies evaluating ESD have shown promising results in other populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gainesville, Florida and 2 other locations
- University of Florida — Gainesville, Florida, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Peter Draganov, MD — University of Florida
- Study coordinator: Peter Draganov, MD
- Email: peter.draganov@medicine.ufl.edu
- Phone: 352-273-9472
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.