PULSAR: PULSed field ablAtion of coloRectal polyps. A pilot study
Research type
Research Study
Full title
PULSAR: PULSed field ablAtion of coloRectal polyps
IRAS ID
353207
Contact name
Amyn Haji
Contact email
Sponsor organisation
Kings College Hospital NHS
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 28 days
Research summary
The purpose of this pilot clinical investigation is to determine the safety of pulsed field ablation (PFA) in the colon and rectum for the removal of colorectal polyps. For patients within this cohort, standard treatments involve surgery and endoscopic surgery, which have associated risks and potential for complications.
In contrast, the risk of patient injury during treatment with EndoVE is no greater than that associated with a routine colonoscopy (1 in 2000), as indicated by pre-clinical studies and clinical experience. This risk assessment is derived from the treatment of over 160 patients with the EndoVE device, during which no adverse events have been recorded.
The anticipated clinical advantage for the wider NHS lies in expediting the treatment of polyps, particularly NICE type 2 polyps, which typically face delays of up to two or three months when awaiting complex Endoscopic Mucosal Resection (EMR) or Endoscopic Submucosal Dissection (ESD) for complex lesions. Moreover, there is a potential reduction in complication rates and improved tolerance compared to EMR/ESD, coupled with a shorter learning curve for procedural training. The primary benefit to the patient is the opportunity to receive PFA treatment on the day of their initial assessment colonoscopy, and will be discharged on the same day, thus eliminating the extended waiting period. Patients will return four to six weeks later for review + resection of the treated area/any residual polyp. All visits align with standard care timelines and no additional bowel preps are required.
REC name
North of Scotland Research Ethics Committee 1
REC reference
25/NS/0006
Date of REC Opinion
17 Feb 2025
REC opinion
Further Information Favourable Opinion