Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate whether a disposable nasal endoscope called E.G. Scan II will visualize the esophagus as well as the standard test, sedated endoscopy.

Detailed Description
-----------------
All subjects underwent two procedures: the E.G.Scan II followed by standard endoscopy in a tandem design. The E.G. Scan II is a transnasal endoscope system to capture and transmit images of the esophagus. Captured images can be reviewed via the E.G. View for diagnosis of diseases related to the esophagus. Generally, the commercial esophagoscope system has reusable probes, but E.G. Scan™ II has a single use probe because reusable probes have the risk of infection and pollution. Prior to the E.G.Scan, subjects received a standard prep for the procedure. The two procedures were performed by two different experienced endoscopists who were blinded to the indication of the procedure. At both procedures a note was made of any abnormality of the esophagus. Every subject with an endoscopic diagnosis of Barrett's Esophagus had clinical biopsies taken to confirm diagnosis. Subject tolerability was measured with a 10-point visual analog scale (VAS) where 0 represented the worst experience and 10 the best experience.

Official Title
-----------------
Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy

Conditions
-----------------
Barrett's Esophagus

Intervention / Treatment
-----------------
* Device: EG Scan II (transnasal endoscopy)
* Procedure: Standard Endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult participants aged 18 years or above who are scheduled for routine upper GI endoscopy for Barrett's Esophagus surveillance, varices surveillance and dyspepsia. Able and willing to give informed consent. Exclusion Criteria: Patients known to be intolerant to endoscopy. Patients with frequent epistaxis. Patients not clinically fit for endoscopy as judged by their care team. Pregnant women. Patients with allergy/sensitivity to Simethicone (Mylicon), Phenylephrine, Lidocaine nasal spray, Benzocaine spray (Topex) Use of anticoagulants or antiplatelets.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subjects with Barrett's Esophagus<br>All subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy. | Device: EG Scan II (transnasal endoscopy)<br> <br> Procedure: Standard Endoscopy<br> <br> |
| Active Comparator: Subjects with Reflux and/or Heartburn<br>All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. | Device: EG Scan II (transnasal endoscopy)<br> <br> Procedure: Standard Endoscopy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Tolerability Score on 10-point Visual Analog Scale (VAS) | On the 10-point VAS, 0 represented the worst experience and 10 the best experience. | Within 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy | Subjects were asked the following question: Based on the overall experience (including need for sedation, ability to drive, time off work, procedure comfort, procedure time, etc.). Which procedure would you prefer to have in the future? Possible answers were: Nasal camera test (EG), oral camera test (Gastroscopy), or either test. | Two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett's, esophagus, reflux, heartburn, screening