Recruiting

EMR-MM & EMR-STSC

Sponsor:

AdventHealth

Code:

NCT06476145

Conditions

Adenoma Colon Polyp

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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)

Conditions

Adenoma Colon Polyp

Study ID

NCT06476145

Start date

Dec 8, 2023

Status verified date

Nov, 2025

Completion date

Jan 8, 2027

Anticipated

Primary completion date

May 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

342 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Adenoma Reocurrance [ Time Frame: 3 - 12 (+/- 6 months) ]

Central Contacts and Locations

Central contacts

Diana Paredes, RN

407-303-5503Diana.Paredes@adventhealth.com

Petronio Martins, MHA

407-303-5503Petronio.martins@adventhealth.com

Locations

AdventHealth

Recruiting

Orlando, Florida, United States, 32804

Contacts

Diana Paredes, RN

407-303-5503Diana.Paredes@adventhealth.com

Petronio Martins, MHA

407-303-5503Petronio.martins@adventhealth.com

Principal Investigator:

Dennis Yang, MD

More Information

Sponsor

AdventHealth

Last update posted

Jan 5, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth on 2026-01-05.