N/A
N=100
Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy
Barrett's Esophagus
Bottom Line
View on ClinicalTrials.gov: NCT02066233 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Median Tolerability Score on 10-point Visual Analog Scale (VAS) — 7; 8; 8; 8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EG Scan II (transnasal endoscopy) (Device); Standard Endoscopy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Tolerability Score on 10-point Visual Analog Scale (VAS) |
7; 8; 8; 8 | — |
| SECONDARY Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy |
21; 18; 4; 11; 17; 15 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02066233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.