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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mayo Clinic
Sponsor:
Collaborator:
IntroMedic Co, LTD
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02066233
First received: February 3, 2014
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Barrett's Esophagus
Device: EG scan (transnasal endoscopy)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of subjects with comparible results using EG scan (transnsal endoscopy) versus clinical sedated endoscopy [ Time Frame: Within 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects with a 5+ experience using 10-point VAS [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    Measured with a 10-point VAS where 0 represents the worse and 10 represents the best experience.


Estimated Enrollment: 100
Study Start Date: March 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Barrett's Esophagus
EG scan (transnasal endoscopy)
Device: EG scan (transnasal endoscopy)
Active Comparator: Reflux and/or heartburn
EG scan (transnasal endoscopy)
Device: EG scan (transnasal endoscopy)

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adult participants aged 18 years or above who are referred 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 history of broken nose, deviated nasal septum or disease of the nasal cavity.
  3. Patients not clinically fit for endoscopy as judged by their care team.
  4. Pregnant women.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066233

Contacts
Contact: Prasad G Iyer, MD 507-255-6930 iyer.prasad@mayo.edu
Contact: Michele L Johnson 507-293-5307 johnson.michele@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michele L Johnson    507-293-5307    johnson.michele@mayo.edu   
Principal Investigator: Prasad G Iyer, MD         
Sponsors and Collaborators
Mayo Clinic
IntroMedic Co, LTD
Investigators
Principal Investigator: Prasad G Iyer, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Prasad G. Iyer, Associate Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02066233     History of Changes
Other Study ID Numbers: 13-008214
Study First Received: February 3, 2014
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Barrett's
esophagus
reflux
heartburn
screening

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 30, 2014