PULSed Field ablAtion of coloRectal Polyps
Pulsed Field Ablation of Colorectal Polyps
King's College Hospital NHS Trust
30 participants
Mar 26, 2025
OBSERVATIONAL
Conditions
Summary
The goal of this observational study is to learn about the role of electroporation (the use of small electric pulses applied to tissue) in the treatment (ablation) of colorectal polyps. The main questions to answer in this pilot phase of the study are: 1. The safety of pulsed field ablation (PFA) for the removal of colorectal polyps 2. The efficacy and feasibility of PFA in the treatment of colorectal polyps using metrics such as treatment coverage, treatment time, post treatment fibrosis, post treatment recurrence and patient satisfaction
Eligibility
Inclusion Criteria5
- > 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 Criteria10
- < 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
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Interventions
The use of pulsed field ablation via irreversible electroporation delivered during flexible lower gastrointestinal endoscopy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06317727