Microwave Coagulation Using CROMA Electrosurgical System

Creo Medical

Status

Completed

Conditions

Polyp of Large Intestine

Treatments

Device: CROMA

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02372552

CML/014/001

Details and patient eligibility

About

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

Full description

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).

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.