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NCT Number: NCT06476145

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)

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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).

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Paredes, RN

CONTACT

[email protected]

407-303-5503

Petronio Martins, MHA

CONTACT

[email protected]

407-303-5503

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ERADICATE

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 26, 2024
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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