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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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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."

Conditions

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Barrett's Esophagus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Subjects with Barrett's Esophagus

All subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy.

Group Type ACTIVE_COMPARATOR

EG Scan II (transnasal endoscopy)

Intervention Type DEVICE

Standard Endoscopy

Intervention Type PROCEDURE

Subjects with Reflux and/or Heartburn

All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.

Group Type ACTIVE_COMPARATOR

EG Scan II (transnasal endoscopy)

Intervention Type DEVICE

Standard Endoscopy

Intervention Type PROCEDURE

Interventions

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EG Scan II (transnasal endoscopy)

Intervention Type DEVICE

Standard Endoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Adult participants aged 18 years or above who are scheduled for routine upper GI endoscopy for Barrett's Esophagus surveillance, varices surveillance and dyspepsia.
2. Able and willing to give informed consent.

Exclusion Criteria

1. Patients known to be intolerant to endoscopy.
2. Patients with frequent epistaxis.
3. Patients not clinically fit for endoscopy as judged by their care team.
4. Pregnant women.
5. Patients with allergy/sensitivity to Simethicone (Mylicon), Phenylephrine, Lidocaine nasal spray, Benzocaine spray (Topex)
6. Use of anticoagulants or antiplatelets.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes