Polyp of Large IntestineNCT02372552
Microwave Coagulation Using CROMA Electrosurgical System
A study testing CROMA in people with Polyp of Large Intestine, run by Creo Medical Limited at 1 site in United Kingdom.
Trial summary
This is a single centre, prospective, non-randomised pivotal clinical investigation to be undertaken at St Mark's Hospital, Harrow, UK. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyp of Large Intestine
- What is being tested?
- CROMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wolfson Unit for Endoscopy, St Mark's Hospital
Harrow, Middlesex, HA1 3UJ
About this study
Official title: Clinical Evaluation of the Safety and Performance of Microwave Coagulation by the CROMA Electrosurgical System During Resection of Complex Colorectal Polyps
This is a single centre, prospective, non-randomised pivotal clinical investigation to be undertaken at St Mark's Hospital, Harrow, UK.
Read the 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).
- Conditions
- Polyp of Large Intestine
- Being tested
- CROMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CROMADevice
Also called Speedboat
Microwave coagulation of small blood vessels
| Study group | Role | What they receive |
|---|---|---|
| CROMA | Experimental | Microwave coagulation of small blood vessels Receives: Device: CROMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Peri-operative
Secondary outcomes (4)
Safety: assessed using reported Adverse Events
Safety will be assessed using reported Adverse Events up to 28w post-operatively
Measured: 28 weeks
Intra-operative complications
The proportion of patients with intra-operative complications will be reported
Measured: Intra-operative
Post-procedural complications
The proportion of patients with post-procedural complications will be reported
Measured: 28 weeks
Clinical outcome
The proportion of patients that go on to require further surgery during the immediate post-operative and follow up periods will be reported
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyp of Large IntestineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creo Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St Mark's Hospital, Harrow, UK
- Responsible party
- Sponsor
- Investigators
- Brian Saunders, Professor, Principal investigator, St. Mark's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372552
- Sponsor's protocol ID
- CML/014/001
- Status last verified
- Feb 2016
- First submitted
- 10 Feb 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Performance of Microwave Coagulation by the CROMA Electrosurgical System During Resection of Complex Colorectal Polyps
- ClinicalTrials.gov ID
- NCT02372552
- Acronym / sponsor ID
- CML/014/001
- Conditions
- Polyp of Large Intestine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Creo Medical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- St Mark's Hospital, Harrow, UK
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CROMA | Experimental | Device: CROMAMicrowave coagulation of small blood vessels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CROMAAlso: SpeedboatMicrowave coagulation of small blood vessels | Device | CROMA |
Primary outcome
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.
4 secondary outcomes
Safety: assessed using reported Adverse Events
Time frame: 28 weeks
Intra-operative complications
Time frame: Intra-operative
Post-procedural complications
Time frame: 28 weeks
Clinical outcome
Time frame: 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Saunders, Professor principal investigator
St. Mark's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CROMA in people with Polyp of Large Intestine, run by Creo Medical Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-coagulation of visible blood vessels and treatment of actively bleeding vessels, ≤1mm in diameter. (time frame: Peri-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.