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
This trial does not accept healthy volunteersQualifiers
> 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 population
Consenting adults with endoscopically confirmed colorectal polyps who fit the inclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Irreversible Electroporation using EndoVE(Endoscopic Vacuum Electrode) and electrical pulses generated using ePORE(electroporation device)
DeviceThe use of pulsed field ablation via irreversible electroporation delivered during flexible lower gastrointestinal endoscopy
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Pulsed Field Ablation group1 intervention
Trial outcomes
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.
Time frame
Month 6Secondary outcomes
1
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 62
Efficacy of pulsed field ablation in the treatment of colorectal polyps
The amount of polyp(s) removed (in percentage)
Time frame
Week 6, Month 63
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 604
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 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College Hospital NHS Trust
Lead sponsor
Mirai Medical
Collaborator
Source ClinicalTrials.gov