Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation (ERADICATE)

December 30, 2025 updated by: AdventHealth

Prospective Randomized Controlled Trial Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation

Non-inferiority trial comparing the recurrence rate of adenomas in non-pedunculated colonic lesions following endoscopic mucosal resection with margin marking (EMR-MM) and endoscopic mucosal resection with thermal margin ablation (EMR-STSC)

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

342

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinic

Description

Inclusion Criteria:

  1. Age 18 years or older
  2. Ability to provide informed consent
  3. Patient scheduled to undergo colonoscopy for the evaluation and removal of colon polyps
  4. Non-pedunculated polyps ≥ 20 mm size

Exclusion Criteria:

  1. Pedunculated polyps
  2. Inflammatory bowel disease
  3. Inability to provide informed consent
  4. Lesions < 20 mm in size (largest dimension)
  5. Lesion involves the lips of the ileocecal valve, is located at the appendiceal orifice and/or is fully circumferential.
  6. Any standard contraindication, including pregnancy, to anesthesia and/or colonoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
EMR-MM
Mucosal markings are placed clearly outside the visible margin of the lesion (polyp) by placing superficial cautery marks with the tip of the endoscopic snare approximately 3 mm away from the polyp margin. Successful marking with diathermy is established by visual identification of white circular "dots" around the entire outer border of the lesion. EMR is then performed as per standard technique as described above.
EMR-STSC
Endoscopic mucosal resection with thermal margin ablation (STSC) will be performed of the entire margin of the mucosal defect, by using a light touch with 1 to 2 mm of the exposed snare tip aiming to create a 2 to 3 mm rim of completely ablated tissue around the entire circumference of the resection defect. Successful STSC is confirmed by the presence of a rim of whitening mucosa around the defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma Reocurrance
Time Frame: 3 - 12 (+/- 6 months)
During Screening Colonoscopy (SC) 1, between 3 -12 post initial procedure. The post-EMR site will be assessed and biopsied for histology to assess for recurrence of adenoma.
3 - 12 (+/- 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EMR procedure time
Time Frame: During procedure visit
Time from submucosal injection to completion of resection, including the time required to treat any intraprocedural adverse event, but not including time on prophylactic endoscopic closure.
During procedure visit
Comparison of MM vs STSC procedure time
Time Frame: Index procedure visit
MM procedure time is defined as that required to complete placing cautery marks around the lesion prior to resection. STSC time is defined as that required to complete margin ablation around the entire resection margin.
Index procedure visit
Incidence of overall severe adverse events: Bleeding
Time Frame: Index procedure, 1 - 3 days post, 30 days.
Severe bleeding (immediate or delayed): defined as the need for hospitalization, transfusion, repeat endoscopy, surgery or interventional radiology. Immediate complication is defined as an event at the time of ESD resection or immediately following colonoscopy (before patient has left the endoscopy unit or during the immediate post-procedural care). A delayed (post-procedure) bleed is defined as an event that occurs after the patient has left the endoscopy unit and within 30 days following the procedure
Index procedure, 1 - 3 days post, 30 days.
Incidence of overall severe adverse events: Perforation
Time Frame: Index procedure, 1 - 3 days post, 30 days.
Defined as complete hole, or full-thickness resection of the muscularis propria (Sidney classification of deep mural injury type IV or V).
Index procedure, 1 - 3 days post, 30 days.
Incidence of overall severe adverse events: Postpolypectomy Syndrome
Time Frame: Index procedure, 1 - 3 days post, 30 days.
Abdominal pain severe enough to warrant emergency room or hospital admission in the presence of fever, leukocytosis, peritoneal inflammation in the absence of frank perforation on CT, and/or required treatment with antibiotics.
Index procedure, 1 - 3 days post, 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Collaborators

Northwestern University
Minneapolis Veterans Affairs Medical Center
Carilion Clinic
Henry Ford Health System
St. Paul's Hospital, Canada
White River Junction Veterans Affairs Medical Center
University Medical Centre Ljubljana
University of Kansas
Rush University

Investigators

  • Principal Investigator: Dennis Yang, MD, AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2023

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

January 8, 2027

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1880214

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be recorded on case report forms created by the AdventHealth PI at each study site and transferred into the AH REDCap system. The site investigator is responsible for complete data ascertainment at the site and entry into the database. Data will be collected centrally at the coordinating center. Each site will maintain a hard copy of the CRF and a de-identified list.

IPD Sharing Time Frame

Records will be kept a minimum of 7 years according to institutional policy. At the end of this time, study records will be disposed of in a secure manner. Electronic data will be deleted from the file it is in and the deleted from the trash folder.

IPD Sharing Access Criteria

All study records will be stored in a locked, research team offices. Only research personnel will have access to study data. Electronic data will be stored on a password encrypted file.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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