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

Primary Purpose

Barrett's Esophagus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EG Scan II (transnasal endoscopy)
Standard Endoscopy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Barrett's Esophagus focused on measuring Barrett's, esophagus, reflux, heartburn, screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Subjects with Barrett's Esophagus

Subjects with Reflux and/or Heartburn

Arm Description

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.

Outcomes

Primary Outcome Measures

Median Tolerability Score on 10-point Visual Analog Scale (VAS)
On the 10-point VAS, 0 represented the "worst experience" and 10 the "best experience."

Secondary Outcome Measures

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

Full Information

First Posted
February 3, 2014
Last Updated
June 6, 2017
Sponsor
Mayo Clinic
Collaborators
IntroMedic Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02066233
Brief Title
Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy
Official Title
Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
IntroMedic Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus
Keywords
Barrett's, esophagus, reflux, heartburn, screening

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects with Barrett's Esophagus
Arm Type
Active Comparator
Arm Description
All subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy.
Arm Title
Subjects with Reflux and/or Heartburn
Arm Type
Active Comparator
Arm Description
All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Intervention Type
Device
Intervention Name(s)
EG Scan II (transnasal endoscopy)
Intervention Type
Procedure
Intervention Name(s)
Standard Endoscopy
Primary Outcome Measure Information:
Title
Median Tolerability Score on 10-point Visual Analog Scale (VAS)
Description
On the 10-point VAS, 0 represented the "worst experience" and 10 the "best experience."
Time Frame
Within 48 hours
Secondary Outcome Measure Information:
Title
Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy
Description
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.
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prasad G Iyer, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30081223
Citation
Sami SS, Iyer PG, Pophali P, Halland M, di Pietro M, Ortiz-Fernandez-Sordo J, White JR, Johnson M, Guha IN, Fitzgerald RC, Ragunath K. Acceptability, Accuracy, and Safety of Disposable Transnasal Capsule Endoscopy for Barrett's Esophagus Screening. Clin Gastroenterol Hepatol. 2019 Mar;17(4):638-646.e1. doi: 10.1016/j.cgh.2018.07.019. Epub 2018 Aug 3.
Results Reference
derived

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

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