Pulsed field ablation for colorectal polyps
Pulsed Field Ablation of Colorectal Polyps
We will test pulsed field ablation to remove colorectal polyps in adults to see if it is safe, effective, and less invasive than current techniques.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06317727 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with at least one treatment-naive, recurrent, or residual colorectal polyp >5 mm located distal to the splenic flexure that meet NICE or JNET type criteria and who can give informed consent are ideal candidates.
Not a fit: Patients with polyps proximal to the splenic flexure, invasive cancer requiring standard resection, those unable to consent, or those who are medically unstable are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide a quicker, less invasive option to remove certain colorectal polyps and potentially reduce the need for surgery.
How similar studies have performed: Electroporation techniques have been used in advanced cancers and other organs, but endoscopic pulsed field ablation for colorectal polyps is novel and currently supported only by limited pilot experience.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
London
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.