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

Not Applicable

Completed

Interventions: Device: EG Scan II (transnasal endoscopy)
Procedure: Standard Endoscopy

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."

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Subjects with Reflux and/or Heartburn	EG Scan II (transnasal endoscopy)	All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Subjects with Reflux and/or Heartburn	Standard Endoscopy	All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Subjects with Barrett's Esophagus	EG Scan II (transnasal endoscopy)	All subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy.
Subjects with Barrett's Esophagus	Standard Endoscopy	All subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy.

Primary Outcome Measures

Name	Time	Method
Median Tolerability Score on 10-point Visual Analog Scale (VAS)	Within 48 hours	On the 10-point VAS, 0 represented the "worst experience" and 10 the "best experience."

Secondary Outcome Measures

Name	Time	Method
Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy	Two weeks	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.