| ISRCTN | ISRCTN70595405 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70595405 |
| ClinicalTrials.gov number | NCT02066233 |
| Secondary identifying numbers | 12466 |
- Submission date
- 16/08/2012
- Registration date
- 16/08/2012
- Last edited
- 07/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Samantha Warburton
Scientific
Scientific
Nottingham University Hospitals NHS Trust
Biomedical Research Centre
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 115 924 9924 ext. 70612 |
|---|---|
| samantha.warburton@nuh.nhs.uk |
Study information
| Study design | Non-randomised interventional and observational trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | ref: 12/EM/0100 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Accuracy in diagnosing Barrett's oesophagus and oesophageal varices |
| Secondary outcome measures | Patients' acceptability |
| Overall study start date | 26/02/2012 |
| Completion date | 26/11/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 150 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 26/02/2012 |
| Date of final enrolment | 26/11/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
Wolfson Digestive Diseases Centre
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Industry
Intromedic Co. Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2019 | Yes | No |
Editorial Notes
07/08/2018: Publication reference added.
30/04/2018: No publications found, verifying study status with principal investigator.
04/03/2016: No publications found, verifying study status with principal investigator.
