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

Barrett's Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066233
• Other study ID #: 13-008214
• Status: Completed
• Phase: N/A
• First received: February 3, 2014
• Last updated: May 16, 2016
• Start date: March 2014
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Will EG Scan (transnasal endoscopy) determine presence of Barrett's Esophagus, esophagitis and hiatal hernia as well as standard sedated endoscopy.

Description:

To evaluate the sensitivity and specificity of E.G.Scan (transnasal endoscopy) in diagnosing Barrett's Esophagus (using standardized endoscopic criteria) compared with the gold standard white light sedated endoscopy.

To look at the sensitivity and specificity of E.G.Scan (transnsasal endoscopy) in diagnosing short segment Barrett's Esophagus, esophagitis and hiatus hernia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Device:
• EG scan (transnasal endoscopy)

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	IntroMedic Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with comparible results using EG scan (transnsal endoscopy) versus clinical sedated endoscopy		Within 48 hours	No
Secondary	Number of subjects with a 5+ experience using 10-point VAS	Measured with a 10-point VAS where 0 represents the worse and 10 represents the best experience.	Two weeks	No