Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Median Tolerability Score on 10-point Visual Analog Scale (VAS)
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."
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Subjects with Barrett's Esophagus
All subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy.
Intervention: EG Scan II (transnasal endoscopy) (Device)
Subjects with Barrett's Esophagus
All subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy.
Intervention: Standard Endoscopy (Procedure)
Subjects with Reflux and/or Heartburn
All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Intervention: EG Scan II (transnasal endoscopy) (Device)
Subjects with Reflux and/or Heartburn
All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Intervention: Standard Endoscopy (Procedure)
Outcomes
Primary Outcomes
Median Tolerability Score on 10-point Visual Analog Scale (VAS)
Time Frame: Within 48 hours
On the 10-point VAS, 0 represented the "worst experience" and 10 the "best experience."
Secondary Outcomes
- Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy(Two weeks)
Investigators
Prasad G. Iyer
Associate Professor of Medicine
Mayo Clinic