PULSed Field ablAtion of coloRectal Polyps

NCT06317727 | Recruiting

• 1 other identifier: IRAS 353207
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 1.The safety of pulsed field ablation (PFA) for the removal of colorectal polyps
2. 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

Conditions

Colon Polyp

Keywords

Colorectal polyps; Irreversible electroporation; Endoscopic ablation

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Safety evaluation will be performed using reported adverse events (AE) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Treatment emergent AEs include intraprocedural and delayed perforation, bleeding and pain.

  Month 6

Secondary Outcomes (7)

• Efficacy of pulsed field ablation in the treatment of colorectal polyps

  Week 6, Month 6

• Efficacy of pulsed field ablation in the treatment of colorectal polyps

  Week 6, Month 6

• Efficacy of pulsed field ablation in the treatment of colorectal polyps

  Week 6, Week 12, Month 6, Month12, Month 36, Month 60

• Efficacy of pulsed field ablation in the treatment of colorectal polyps

  Week 6, Month 6

• Efficacy of pulsed field ablation in the treatment of colorectal polyps

  Week 6, Month 6

Study Arms (1)

Pulsed Field Ablation group

The EndoVE (Endoscopic vacuum electrode) is moved endoscopically into surface contact with the polyp. A vacuum is employed through the EndoVE as required to assist contact with the device. An electrical field depth of 8-10mm and surface area of 2cm3 is treated per pulse application. The electrical pulses are produced by an electroporation generator (ePORE device). Larger polyps will require multiple applications to ensure the full surface area has been treated. An overlap with previously pulsed areas is preferable to ensure all of the polyp tissue is ablated. The patient will then be transferred to the step-down ward to monitor for any adverse events before being discharged on the same day. The patient will be requested to attend the clinic for an endoscopy follow up at 4-6 weeks post EndoVE polyp treatment to investigate the response.

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

Interventions

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

The use of pulsed field ablation via irreversible electroporation delivered during flexible lower gastrointestinal endoscopy

Pulsed Field Ablation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consenting adults with endoscopically confirmed colorectal polyps who fit the inclusion criteria.

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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Mirai Medical: collaborator

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy specimen of the colorectal mucosa after the ablation therapy to determine residual or recurrent polyps

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ademola A Adeyeye, MBBS,MSc,FRCS,FEBS, FMAS, PGDE

CONTACT

02032993210; ademola.adeyeye1@nhs.net

Amyn Haji, MA,MBBChir,MSc,MD,FRCS

CONTACT

amynhaji@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 19, 2024
• Study Start: March 26, 2025
• Primary Completion: February 27, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2025-03

Locations

GB (1)