Condition category
Digestive System
Date applied
16/08/2012
Date assigned
16/08/2012
Last edited
04/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 Barrett’s 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

http://www.nottingham.ac.uk/

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

Publication citations

Additional files

Editorial Notes

04/03/2016: No publications found, verifying study status with principal investigator.