Microwave Coagulation Using CROMA Electrosurgical System

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

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

Study Overview

• Status: Completed
• Conditions: Polyp of Large Intestine
• Intervention / Treatment: Device: CROMA

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesex
    • Harrow, Middlesex, United Kingdom, HA1 3UJ
      • Wolfson Unit for Endoscopy, St Mark's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CROMA; Microwave coagulation of small blood vessels	Device: CROMA; Microwave coagulation of small blood vessels; Other Names: Speedboat

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Creo Medical Limited
• Collaborators: St Mark's Hospital, Harrow, UK
• Investigators: Principal Investigator: Brian Saunders, Professor, St. Mark's Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 25, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Estimate): July 26, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: CML/014/001