Microwave Coagulation Using CROMA Electrosurgical System

Not Applicable

Completed

• Conditions: Polyp of Large Intestine
• Interventions: Device: CROMA

• Registration Number: NCT02372552
• Lead Sponsor: Creo Medical Limited

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-25
• Study First Posted: 2015-02-26
• Study Start: 2015-08
• Status Verified: 2016-02
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CROMA	CROMA	Microwave coagulation of small blood vessels

Primary Outcome Measures

Name	Time	Method
Pre-coagulation of visible blood vessels and treatment of actively bleeding vessels, ≤1mm in diameter.	Peri-operative	Performance will be assessed on the basis of number of vessels successfully coagulated.

Secondary Outcome Measures

Name	Time	Method
Post-procedural complications	28 weeks	The proportion of patients with post-procedural complications will be reported
Clinical outcome	28 weeks	The proportion of patients that go on to require further surgery during the immediate post-operative and follow up periods will be reported
Safety: assessed using reported Adverse Events	28 weeks	Safety will be assessed using reported Adverse Events up to 28w post-operatively
Intra-operative complications	Intra-operative	The proportion of patients with intra-operative complications will be reported

Trial Locations

Locations (1)

Wolfson Unit for Endoscopy, St Mark's Hospital; 🇬🇧 Harrow, Middlesex, United Kingdom