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Microwave Coagulation Using CROMA Electrosurgical System

Primary Purpose

Polyp of Large Intestine

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CROMA
Sponsored by
Creo Medical Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polyp of Large Intestine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wolfson Unit for Endoscopy, St Mark's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CROMA

Arm Description

Microwave coagulation of small blood vessels

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety: assessed using reported Adverse Events
Safety will be assessed using reported Adverse Events up to 28w post-operatively
Intra-operative complications
The proportion of patients with intra-operative complications will be reported
Post-procedural complications
The proportion of patients with post-procedural complications will be reported
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

Full Information

First Posted
February 10, 2015
Last Updated
July 25, 2016
Sponsor
Creo Medical Limited
Collaborators
St Mark's Hospital, Harrow, UK
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1. Study Identification

Unique Protocol Identification Number
NCT02372552
Brief Title
Microwave Coagulation Using CROMA Electrosurgical System
Official Title
Clinical Evaluation of the Safety and Performance of Microwave Coagulation by the CROMA Electrosurgical System During Resection of Complex Colorectal Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creo Medical Limited
Collaborators
St Mark's Hospital, Harrow, UK

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyp of Large Intestine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CROMA
Arm Type
Experimental
Arm Description
Microwave coagulation of small blood vessels
Intervention Type
Device
Intervention Name(s)
CROMA
Other Intervention Name(s)
Speedboat
Intervention Description
Microwave coagulation of small blood vessels
Primary Outcome Measure Information:
Title
Pre-coagulation of visible blood vessels and treatment of actively bleeding vessels, ≤1mm in diameter.
Description
Performance will be assessed on the basis of number of vessels successfully coagulated.
Time Frame
Peri-operative
Secondary Outcome Measure Information:
Title
Safety: assessed using reported Adverse Events
Description
Safety will be assessed using reported Adverse Events up to 28w post-operatively
Time Frame
28 weeks
Title
Intra-operative complications
Description
The proportion of patients with intra-operative complications will be reported
Time Frame
Intra-operative
Title
Post-procedural complications
Description
The proportion of patients with post-procedural complications will be reported
Time Frame
28 weeks
Title
Clinical outcome
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Saunders, Professor
Organizational Affiliation
St. Mark's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wolfson Unit for Endoscopy, St Mark's Hospital
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Microwave Coagulation Using CROMA Electrosurgical System

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