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

Mayo Clinic

Status: Completed

Conditions: Barrett's Esophagus

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02066233

13-008214

Details and patient eligibility

About

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.

Full 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."

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Subjects with Barrett's Esophagus

Active Comparator group

Description:

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

Treatment:

Procedure: Standard Endoscopy

Device: EG Scan II (transnasal endoscopy)

Subjects with Reflux and/or Heartburn

Active Comparator group

Description:

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

Treatment:

Procedure: Standard Endoscopy

Device: EG Scan II (transnasal endoscopy)