NCT02372552

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 26, 2016

Status Verified

February 1, 2016

Enrollment Period

10 months

First QC Date

February 10, 2015

Last Update Submit

July 25, 2016

Conditions

Polyp of Large Intestine

Outcome Measures

Primary Outcomes (1)

  • 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 (4)

  • Safety: assessed using reported Adverse Events

    28 weeks

  • Intra-operative complications

    Intra-operative

  • Post-procedural complications

    28 weeks

  • Clinical outcome

    28 weeks

Study Arms (1)

CROMA

EXPERIMENTAL

Microwave coagulation of small blood vessels

Device: CROMA

Interventions

CROMADEVICE

Microwave coagulation of small blood vessels

Also known as: Speedboat
CROMA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson Unit for Endoscopy, St Mark's Hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Study Officials

  • Brian Saunders, Professor

    St. Mark's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 26, 2015

Study Start

August 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 26, 2016

Record last verified: 2016-02

Locations

GB(1)