Microwave Coagulation Using CROMA Electrosurgical System | NCT02372552

Studies
Microwave Coagulation Using CROMA Electrosurgical System

NCT02372552

Sponsor

Creo Medical Limited

Status

Completed

Last Update Posted

Jul 26, 2016Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Polyp of Large Intestine

Interventions

CROMA

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Feb 10, 2015

First Submission Date that Met QC Criteria

Feb 25, 2015

First Posted Date

Feb 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2016

Last Update Posted Date

Jul 26, 2016Estimated

Name	Class
St Mark's Hospital, Harrow, UK	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CROMA	Experimental	Microwave coagulation of small blood vessels	Device: CROMA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CROMA	Device	Microwave coagulation of small blood vessels	CROMA	Speedboat

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian Saunders, Professor	St. Mark's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wolfson Unit for Endoscopy, St Mark's Hospital		Harrow	Middlesex	HA1 3UJ	United Kingdom