An observational study in Colon Polyp, sponsored by King's College Hospital NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by King's College Hospital NHS Trust · Observational
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:
Colorectal cancer is the commonest cancer of the digestive tract, the second commonest cause of cancer deaths in the western hemisphere and the third commonest cancer in the United Kingdom. Most bowel cancers arise from precancerous growths called polyps. Prompt and effective treatment of these polyps can potentially prevent or cure bowel cancer at its earliest stages. King's College Hospital runs a special service dedicated to treating these lesions called the Special Polyps and Early Colorectal Cancer Service (SPECCS) using a variety of methods. These techniques usually involve removing the polyps through endoscopic resection. Other options include laparoscopic surgery, robotic surgery and rarely, open surgery. These modalities of treatments come with a number of risks, are highly invasive, require extensive skill and also have a long waiting list.
Endoscopic ablation with electroporation offers the potential of treating colorectal polyps in an easier, faster and less invasive manner. Electroporation uses small, high frequency, electric pulses, applied on the surface of tissues to temporarily open up pores in the outer wall of these cells. These pores, disrupts the structure of the abnormal cells and cause cell death via apoptosis. This approach has been used to treat frail patients with advanced colored cancer who cannot undergo more aggressive forms of treatment and it is postulated that this technology also has the ability to deal with colorectal polyps. This study is a pilot research involving a small number of patients with colorectal polyps who will be treated with electroporation given during colonoscopy.
Patients who participate in this study will be treated using endoscopic electroporation with the intent of ablating NICE (Narrow Band Imaging International Colorectal Endoscopic classification) Type 1 or Type 2 colorectal polyps. The treatment will typically be carried out under sedation. Small risks for this procedure include complications such as bleeding, intestinal perforation, infection and an adverse reaction to the anaesthetic medication. Patients who have been treated with electroporation have also reported the following symptoms following treatment: pyrexia, obstipation, diarrhea, pyrexia, nausea, headaches, and joint pain. Patients will be required to return for the first follow-up visit, approximately 6 weeks after the initial treatment, at which time they will need to have a colonoscopy. If there is evidence that the initial treatment has not removed 100% of the polyp, an additional treatment will be offered, or the polyp will be removed by Endoscopic Mucosal Resection (EMR) which is the standard treatment for this indication. This decision will be taken by the patient's primary physician. Patients who have an additional treatment will return approximately 12 weeks after the initial treatment for another colonoscopy that falls outside of standard of care protocol. All other visits fall under the standard care timelines. Patients who have successfully been treated with endoscopic ablation will undergo a biopsy at either the first, or second follow up visit to exclude residual disease. This will be performed when the patient is under sedation
Clinical review and colonoscopy will be repeated at 6weeks, 6months and 5years from initial contact to assess the effectiveness on the polyp and the safety of the patient
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's planned enrollment of 30 is below the median of 411 across 115 observational studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →King's College Hospital NHS Trust is the lead sponsor of 171 studies on the registry; 56 are open to participants now.
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Consenting adults with endoscopically confirmed colorectal polyps who fit the inclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
The use of pulsed field ablation via irreversible electroporation delivered during flexible lower gastrointestinal endoscopy
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.
Time frame: Month 6
Efficacy of pulsed field ablation in the treatment of colorectal polyps
Efficacy will be assessed by reviewing the number of polyps that require retreatment following the initial PFA treatment. Images obtained during standard colonoscopies will be used for this assessment.
Time frame: Week 6, Month 6
Efficacy of pulsed field ablation in the treatment of colorectal polyps
The amount of polyp(s) removed (in percentage)
Time frame: Week 6, Month 6
Efficacy of pulsed field ablation in the treatment of colorectal polyps
The rate of recurrence of colorectal polyp (in percentage)
Time frame: Week 6, Week 12, Month 6, Month12, Month 36, Month 60
Efficacy of pulsed field ablation in the treatment of colorectal polyps
The number of polyp(s) treated per session (in numerical value)
Time frame: Week 6, Month 6
Efficacy of pulsed field ablation in the treatment of colorectal polyps
The time required for each session of treatment (in seconds)
Time frame: Week 6, Month 6
Efficacy of pulsed field ablation in the treatment of colorectal polyps
The 'non-lifting sign' for fibrosis (either present or absent)
Time frame: Week 6, Month 6
Evaluation of Quality of Life following pulsed field ablation treatment of colorectal polyps
Change in Quality of Life Patient Reported Outcomes as measured by Short Form 12 (SF-12) Questionnaire. The scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time frame: Baseline, Week 6, Week 12, Month 6, Month 12, Month 36, Month 60
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