Microwave Coagulation Using CROMA Electrosurgical System

Creo Medical Limited30 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polyp of Large Intestine

Interventions

CROMADEVICE

Microwave coagulation of small blood vessels

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Wolfson Unit for Endoscopy, St Mark's Hospital

Harrow, Middlesex, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Peri-operative

Secondary Outcomes

Safety: assessed using reported Adverse Events

Safety will be assessed using reported Adverse Events up to 28w post-operatively

Time frame: 28 weeks

Intra-operative complications

The proportion of patients with intra-operative complications will be reported

Time frame: Intra-operative

Post-procedural complications

The proportion of patients with post-procedural complications will be reported

Time frame: 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

Time frame: 28 weeks

Data from ClinicalTrials.gov

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