Contact information
Type
Scientific
Primary contact
Mrs Samantha Warburton
ORCID ID
Contact details
Nottingham University Hospitals NHS Trust
Biomedical Research Centre
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
+44 115 924 9924 ext. 70612
samantha.warburton@nuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12466
Study information
Scientific title
A multi-centre observational study to assess a novel endoscopic device in imaging the upper gastrointestinal (GI) tract: The E.G. Scan Study
Acronym
Study hypothesis
There are certain silent conditions like Barretts Oesophagus (a condition which can rarely cause cancer of the gullet) and Oesophageal Varices (swollen veins in the gullet which can sometimes cause serious bleeding) that can happen in patients who may otherwise not have any symptoms. If these are detected and treated early then patients could potentially avoid future serious complications. In order to detect these conditions, doctors have to perform tests on a large number of patients who are likely to have them, but unfortunately this cannot be done in the NHS at the moment partly because there is no agreement among specialists as to what is the best test to use.
Although a standard camera test can detect these conditions, it is not suitable to use for this purpose because it has many limitations. It is performed in the hospital usually under conscious sedation to increase comfort. Performing the test demands a lot of planning and has many cost considerations as it requires patient observation, experienced nursing staff, recovery rooms, cleaning equipment and medications.
There is a lot of research evidence that transnasal cameras (very thin cameras inserted through the nose) are more comfortable to patients because they do not cause gagging and retching, therefore do not require sedation. They are safer than standard cameras and are as accurate.
The purpose of this study is to compare a new camera called The E.G. scan to the standard camera test. We want to know whether it is as accurate and also whether it is acceptable to patients. It is much thinner than the standard camera test, therefore can be inserted through the nose with less chance of retching and gagging. It does not need sedation. The camera tube is disposable so there is no risk of cross contamination. The results of this study will help us decide whether this new camera might be the ideal test to detect patients with these two conditions and potentially benefit the wider population.
Ethics approval
ref: 12/EM/0100
Study design
Non-randomised interventional and observational trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Oral and Gastrointestinal disease
Intervention
Description: 50 Barrett's cases 50 dyspepsia/heartburn controlls 50 chronic liver disease patients
EG scan, ultrathin transnasal imaging endoscope followed up at 1 month.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Accuracy in diagnosing Barrett's oesophagus and oesophageal varices
Secondary outcome measures
Patients' acceptability
Overall trial start date
26/02/2012
Overall trial end date
26/11/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult participants aged 18 years or above who are referred for routine upper GI endoscopy for BO surveillance, varices surveillance and dyspepsia.
2. Able and willing to give informed consent.
3. Male and female participants
4. >18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 150
Participant exclusion criteria
1. Patients known to be intolerant to endoscopy
2. Patients with history of broken nose, deviated nasal septum or disease of the nasal cavity
3. Patients not clinically fit for endoscopy as judged by their caring team
4. Pregnant women
Recruitment start date
26/02/2012
Recruitment end date
26/11/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
Wolfson Digestive Diseases Centre
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Intromedic Co. Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary