PULSed Field ablAtion of coloRectal Polyps
Recruiting now
Conditions studied: Colon Polyp
In brief
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
Key facts
- Study ID
- NCT06317727
- Run by
- King's College Hospital NHS Trust
- People needed
- 30
- Starts
- 2025-03-26
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- > 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
You may not qualify if…
- < 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 is running
- King's College Hospital — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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