PULSed Field ablAtion of coloRectal Polyps

ConditionColon Polyp

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorKing's College Hospital NHS Trust

About this trial

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 criteria

Qualifiers

> 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

Disqualifiers

< 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

Trial design

Treatments tested in this trial

Irreversible Electroporation using EndoVE(Endoscopic Vacuum Electrode) and electrical pulses generated using ePORE(electroporation device)

Treatment groups

30 Participants

are divided into 1 treatment group

Sponsors and collaborators

King's College Hospital NHS Trust

Lead sponsor

Mirai Medical

Collaborator

Source ClinicalTrials.gov