Pulsed field ablation for colorectal polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot observational study using endoscopic electroporation (EndoVE with ePORE pulses) to treat colorectal polyps and record safety and feasibility outcomes. Investigators will collect metrics such as treatment coverage, treatment time, post-treatment fibrosis, recurrence, and patient satisfaction after procedures performed at a specialist tertiary center. Eligible adults have at least one polyp >5 mm located distal to the splenic flexure and are classified by NICE or JNET criteria as suitable for endoscopic ablation. Results will inform whether larger, controlled trials are warranted and how this technique compares to standard endoscopic resection or surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* \> 18 years of age.
* Ability to review the consent form prior to enrolment into the study • Patients must be mentally capable of understanding the information given • Patients must give written informed consent prior to undergoing any study-specific procedures.
* Patients must have at least one polyp (treatment naive, recurrent or residual) measuring \>5mm, located distal to the splenic flexure(i.e descending colon, Sigmoid colon, recto sigmoid junction and the rectum above the dentate line)
* Polyp(s) must be classified as Type 1 or Type 2, based on NICE (Narrow Band Imaging International Colorectal Endoscopic) classification; OR Type 1 or Type 2A /2B based on JNET (Japan Narrow Band Imaging Expert Team) classification
* Patients must have a World Health Organization (WHO) performance status ≤ 2 . Patients must have a life expectancy of at least 6 months

Exclusion Criteria:

* \< 18 years of age.
* Patients who are incapacitated, unconscious or from a vulnerable population. • Patient who is pregnant or breastfeeding
* Patients unable to provide their own informed consent
* Patients with complex / challenging polyp(s), including but not limited to those that are: o \>20mm in size o Flat/bulky in shape o Extending beyond 2 haustra folds or occupying more than 1/3rd of the lumenal circumference o Located on the right colon proximal to the splenic flexure, ileocecal valve, hepatic and splenic flexure or dentate line of the rectum o Fibrosis from large lateral spreading lesions
* Patients with NICE Type 3 category polyps, OR JNET Type 3 polyps OR Kudo Vi pit pattern polyps
* Patients with British Society of Gastroenterology (BSG) category C (high risk polyps).
* Five or more polyps in a single patient
* Grossly inflamed colonic mucosa with bleeding or ulcers
* Implanted colonic stents
* Polyposis syndromes

Where it's running

• King's College Hospital
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Ademola A Adeyeye, MBBS,MSc,FRCS,FEBS, FMAS, PGDE
• Email: ademola.adeyeye1@nhs.net
• Phone: 02032993210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.