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

This study has been completed.
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: June 6, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Barrett's Esophagus Device: EG Scan II (transnasal endoscopy) Procedure: Standard Endoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Prasad G. Iyer, Mayo Clinic:

Primary Outcome Measures:
  • Median Tolerability Score on 10-point Visual Analog Scale (VAS) [ Time Frame: Within 48 hours ]
    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 [ Time Frame: Two weeks ]
    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.


Enrollment: 100
Study Start Date: March 2014
Study Completion Date: March 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subjects with Barrett's Esophagus
All subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy.
Device: EG Scan II (transnasal endoscopy) Procedure: Standard Endoscopy
Active Comparator: Subjects with Reflux and/or Heartburn
All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Device: EG Scan II (transnasal endoscopy) Procedure: Standard 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."

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
IntroMedic Co., Ltd.
Investigators
Principal Investigator: Prasad G Iyer, MD Mayo Clinic
  More Information

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
Results First Received: May 1, 2017
Last Updated: June 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Prasad G. Iyer, 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 21, 2017