Digestive System Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

Gastroesophageal Reflux

Heartburn

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

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

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

EG Scan II (transnasal endoscopy)

Standard Endoscopy

Prasad G Iyer, MD

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.

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."

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

On the 10-point VAS, 0 represented the "worst experience" and 10 the "best experience."

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.

IntroMedic Co., Ltd.

Mayo Clinic

Associate Professor of Medicine

Presenting adverse events per per intervention was not possible, as most patients were sedated prior to the procedures and only a few were not sedated. Therefore the adverse events were per patient population (study arm).

Subjects With Barrett's Esophagus

Subjects With Reflux and/or Heartburn

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Prasad G. Iyer

EG II Scan

Median Tolerability Score on 10-point Visual Analog Scale (VAS)

Nasal Camera Test

Oral Camera Test

Either Test

Two subjects on the reflux and/or heartburn arm didn't answer this question.

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

EG Scan II (Day 1)

Standard Endoscopy (Day 2)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy	NCT02066233	Barrett's Esoph...	EG Scan II (tra... Standard Endosc...	18 Years -	Mayo Clinic
Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy	NCT02066233	Barrett's Esoph...	EG Scan II (tra... Standard Endosc...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for eg scan ii (transnasal endoscopy)