Actively Recruiting
Pulsed Field Ablation of Colorectal Polyps Using Endoscopic Electroporation
Led by King's College Hospital NHS Trust · Updated on 2026-03-03
30
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
K
King's College Hospital NHS Trust
Lead Sponsor
M
Mirai Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of electroporation, a technique applying small electric pulses to tissue, in treating colorectal polyps. This observational pilot study aims to evaluate the safety, effectiveness, and feasibility of pulsed field ablation (PFA) for removing these polyps. The study is important because colorectal cancer often develops from polyps, and treating them early may help prevent cancer progression. King's College Hospital is conducting the research using this less invasive method compared to traditional surgeries. Participants will receive treatment with the EndoVE device, which uses vacuum-assisted endoscopic contact combined with electrical pulses from the ePORE electroporation generator during colonoscopy. The electrical field targets the polyp tissue to induce cell death. The procedure is done under sedation, typically on the same day with short hospital observation. Larger polyps may require multiple pulse applications to ensure full coverage. Follow-up colonoscopies occur around 6 weeks after treatment, with possible additional treatment or standard removal if needed. During the study, participants will have clinical reviews and colonoscopies at 6 weeks, 6 months, and 5 years after initial treatment to monitor polyp response and safety. Biopsies may be taken during follow-ups under sedation to check for remaining disease. Researchers will assess treatment side effects, polyp removal success, recurrence, patient satisfaction, and quality of life. The primary outcome focuses on adverse events within 6 months, with multiple secondary outcomes evaluating efficacy and patient well-being over time.
CONDITIONS
Brief Title
PULSed Field ablAtion of coloRectal Polyps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be older than 18 years.
- Ability to understand and review the consent form before joining the study.
- Must have at least one treatment-naive, recurrent, or residual polyp larger than 5mm located distal to the splenic flexure.
- Polyps must be classified as Type 1 or Type 2 by NICE classification or Type 1 or Type 2A/2B by JNET classification.
- Participants must have a WHO performance status of 2 or less and a life expectancy of at least 6 months.
- Must provide written informed consent prior to any study procedures.
You will not qualify if you...
- Participants younger than 18 years.
- Patients who are incapacitated, unconscious, or from a vulnerable population.
- Pregnant or breastfeeding individuals.
- Those unable to give informed consent.
- Patients with complex or challenging polyps including those larger than 20mm, flat or bulky shape, extending beyond two haustra folds, or occupying more than one-third of the lumen circumference.
- Polyps located in the right colon proximal to the splenic flexure, ileocecal valve, hepatic and splenic flexure, or dentate line of the rectum.
- Polyps with fibrosis from large lateral spreading lesions.
- Polyps classified as NICE Type 3, JNET Type 3, or Kudo Vi pit pattern.
- Patients with British Society of Gastroenterology Category C high-risk polyps.
- Having five or more polyps.
- Presence of grossly inflamed colonic mucosa with bleeding or ulcers.
- Implanted colonic stents.
- Diagnosis of polyposis syndromes.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure with same-day discharge
Participants receive pulsed field ablation treatment using endoscopic electroporation during a colonoscopy to ablate colorectal polyps.
1 visit (in-person, under sedation)
Duration - Approximately 6 weeks
Participants return for follow-up colonoscopy and clinical review approximately 6 weeks after initial treatment to assess treatment response and determine if additional treatment is needed. Biopsy may be performed under sedation to exclude residual disease.
1 visit (in-person, under sedation)
Duration - Approximately 6 weeks after first follow-up
If additional treatment is required, participants will have a second follow-up colonoscopy and clinical review approximately 12 weeks after initial treatment to assess outcomes and perform biopsy if needed.
1 visit (in-person, under sedation)
Duration - Up to 5 years
Participants undergo clinical review and colonoscopy at 6 months and 5 years after initial treatment to assess long-term safety and effectiveness of the pulsed field ablation.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
King's College Hospital
London, United Kingdom, SE5 9RS
Actively Recruiting
Research Team
A
Ademola A Adeyeye, MBBS,MSc,FRCS,FEBS, FMAS, PGDE
A
Amyn Haji, MA,MBBChir,MSc,MD,FRCS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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