Microwave Coagulation Using CROMA Electrosurgical System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-06-30

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.

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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).

Conditions

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Polyp of Large Intestine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CROMA

Microwave coagulation of small blood vessels

Group Type EXPERIMENTAL

CROMA

Intervention Type DEVICE

Microwave coagulation of small blood vessels

Interventions

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CROMA

Microwave coagulation of small blood vessels

Intervention Type DEVICE

Other Intervention Names

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Speedboat

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No