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Completed

NCT Number: NCT02372552

Microwave Coagulation Using CROMA Electrosurgical System

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

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Key information

Conditions

Polyp of Large Intestine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wolfson Unit for Endoscopy, St Mark's Hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CROMA

Device

Microwave coagulation of small blood vessels

Other names: Speedboat

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Creo Medical Limited

Industry

Collaborators

  • St Mark's Hospital, Harrow, UK

Registry information

Official study title

Clinical Evaluation of the Safety and Performance of Microwave Coagulation by the CROMA Electrosurgical System During Resection of Complex Colorectal Polyps

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 26, 2015
Registry last updated
Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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