NCT02372552CompletedNot Applicable
Clinical Evaluation of the Safety and Performance of Microwave Coagulation by the CROMA Electrosurgical System During Resection of Complex Colorectal Polyps
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Creo Medical Limited
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Pre-coagulation of visible blood vessels and treatment of actively bleeding vessels, ≤1mm in diameter.
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Study Sites (2)
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