Microwave Coagulation Using CROMA Electrosurgical System

Clinical Evaluation of the Safety and Performance of Microwave Coagulation by the CROMA Electrosurgical System During Resection of Complex Colorectal Polyps

This is a single centre, prospective, non-randomised pivotal clinical investigation to be undertaken at St Mark's Hospital, Harrow, UK.

The study will recruit 30 patients undergoing endoscopic resection of complex colorectal polyps and be used to demonstrate safety and performance of the CROMA Electrosurgical System microwave coagulation modality. Study data will complement existing data to support a CE marking application for the CROMA Electrosurgical System (combined RF and microwave modalities).

Inclusion Criteria:

• Male or female, at least 18 years of age;
• After standard clinical work-up a benign appearing lower bowel lesion >2cm in diameter;
• Patient or authorised representative able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

• Aged <18 years of age;
• Pregnant or lactating females;
• Lower bowel lesions <2cm in diameter;
• Patients receiving regular systemic steroids;
• Patients who are immuno-compromised (either acquired or congenital);
• Patients with a known coagulopathy (either acquired or congenital);
• Patients on anti-platelet therapy at the time of the procedure, apart from low dose (75mg) aspirin alone;
• Concurrent participation in another experimental intervention or drug study;
• Unwilling or unable to provide informed consent.