Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
July 6, 2017
CompletedJuly 6, 2017
June 1, 2017
1.6 years
February 3, 2014
May 1, 2017
June 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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."
Within 48 hours
Secondary Outcomes (1)
Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy
Two weeks
Study Arms (2)
Subjects with Barrett's Esophagus
ACTIVE COMPARATORAll subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy.
Subjects with Reflux and/or Heartburn
ACTIVE COMPARATORAll subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- IntroMedic Co., Ltd.collaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
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.
PMID: 30081223DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Prasad G. Iyer
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Prasad G Iyer, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
February 3, 2014
First Posted
February 19, 2014
Study Start
March 1, 2014
Primary Completion
October 1, 2015
Study Completion
March 1, 2016
Last Updated
July 6, 2017
Results First Posted
July 6, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share