Colorectal Polyps Clinical Trials

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Pulsed Field Ablation of Colorectal Polyps

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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. 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \> 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

Locations
Other Locations
United Kingdom
King's College Hospital
RECRUITING
London
Contact Information
Primary
Ademola A Adeyeye, MBBS,MSc,FRCS,FEBS, FMAS, PGDE
ademola.adeyeye1@nhs.net
02032993210
Backup
Amyn Haji, MA,MBBChir,MSc,MD,FRCS
amynhaji@nhs.net
Time Frame
Start Date: 2025-03-26
Estimated Completion Date: 2028-02
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Mirai Medical
Leads: King's College Hospital NHS Trust

This content was sourced from clinicaltrials.gov