Microwave Coagulation Using CROMA Electrosurgical System

Polyp of Large Intestine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372552
• Other study ID #: CML/014/001
• Status: Completed
• Phase: N/A
• First received: February 10, 2015
• Last updated: July 25, 2016
• Start date: August 2015
• Est. completion date: June 2016

Study information

• Verified date: February 2016
• Source: Creo Medical Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polyp of Large Intestine
• Polyps

Intervention

Device:
• CROMA
Microwave coagulation of small blood vessels

Locations

Country	Name	City	State
United Kingdom	Wolfson Unit for Endoscopy, St Mark's Hospital	Harrow	Middlesex

Sponsors (2)

Lead Sponsor	Collaborator
Creo Medical Limited	St Mark's Hospital, Harrow, UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety: assessed using reported Adverse Events	Safety will be assessed using reported Adverse Events up to 28w post-operatively	28 weeks	Yes
Secondary	Intra-operative complications	The proportion of patients with intra-operative complications will be reported	Intra-operative	No
Secondary	Post-procedural complications	The proportion of patients with post-procedural complications will be reported	28 weeks	No
Secondary	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	No