Skip to main content
OpenTrials
Completed

NCT Number: NCT02066233

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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."

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EG Scan II (transnasal endoscopy)

Device

Standard Endoscopy

Procedure

Primary outcomes

  1. 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

  1. Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • IntroMedic Co., Ltd.

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Feb 19, 2014
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.