Microwave Coagulation Using CROMA Electrosurgical System

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

Detailed Description
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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).

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

Conditions
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Polyp of Large Intestine

Intervention / Treatment
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* Device: CROMA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CROMA<br>Microwave coagulation of small blood vessels | Device: CROMA<br>* Microwave coagulation of small blood vessels<br>* Other names: Speedboat;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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