NCT02372552
Completed
Not Applicable
Clinical Evaluation of the Safety and Performance of Microwave Coagulation by the CROMA Electrosurgical System During Resection of Complex Colorectal Polyps
ConditionsPolyp of Large Intestine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Polyp of Large Intestine
- Sponsor
- Creo Medical Limited
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pre-coagulation of visible blood vessels and treatment of actively bleeding vessels, ≤1mm in diameter.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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).
Investigators
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.
Outcomes
Primary Outcomes
Pre-coagulation of visible blood vessels and treatment of actively bleeding vessels, ≤1mm in diameter.
Time Frame: Peri-operative
Performance will be assessed on the basis of number of vessels successfully coagulated.
Secondary Outcomes
- Post-procedural complications(28 weeks)
- Clinical outcome(28 weeks)
- Safety: assessed using reported Adverse Events(28 weeks)
- Intra-operative complications(Intra-operative)
Study Sites (1)
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