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Microwave Coagulation Using CROMA Electrosurgical System

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ClinicalTrials.gov Identifier: NCT02372552
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : July 26, 2016
Sponsor:
Collaborator:
St Mark's Hospital, Harrow, UK
Information provided by (Responsible Party):
Creo Medical Limited

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

Condition or disease Intervention/treatment Phase
Polyp of Large Intestine Device: CROMA Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Safety and Performance of Microwave Coagulation by the CROMA Electrosurgical System During Resection of Complex Colorectal Polyps
Study Start Date : August 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: CROMA
Microwave coagulation of small blood vessels
Device: CROMA
Microwave coagulation of small blood vessels
Other Name: Speedboat




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Safety: assessed using reported Adverse Events [ Time Frame: 28 weeks ]
    Safety will be assessed using reported Adverse Events up to 28w post-operatively

  2. Intra-operative complications [ Time Frame: Intra-operative ]
    The proportion of patients with intra-operative complications will be reported

  3. Post-procedural complications [ Time Frame: 28 weeks ]
    The proportion of patients with post-procedural complications will be reported

  4. Clinical outcome [ Time Frame: 28 weeks ]
    The proportion of patients that go on to require further surgery during the immediate post-operative and follow up periods will be reported



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372552


Locations
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United Kingdom
Wolfson Unit for Endoscopy, St Mark's Hospital
Harrow, Middlesex, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Creo Medical Limited
St Mark's Hospital, Harrow, UK
Investigators
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Principal Investigator: Brian Saunders, Professor St. Mark's Hospital
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Responsible Party: Creo Medical Limited
ClinicalTrials.gov Identifier: NCT02372552    
Other Study ID Numbers: CML/014/001
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Polyps
Pathological Conditions, Anatomical