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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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ClinicalTrials.gov Identifier: NCT02066233
Recruitment Status : Completed
First Posted : February 19, 2014
Results First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
IntroMedic Co., Ltd.
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic

February 3, 2014
February 19, 2014
May 1, 2017
July 6, 2017
July 6, 2017
March 2014
October 2015   (Final data collection date for primary outcome measure)
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."
Number of subjects with comparible results using EG scan (transnsal endoscopy) versus clinical sedated endoscopy [ Time Frame: Within 48 hours ]
Complete list of historical versions of study NCT02066233 on ClinicalTrials.gov Archive Site
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.
Number of subjects with a 5+ experience using 10-point VAS [ Time Frame: Two weeks ]
Measured with a 10-point VAS where 0 represents the worse and 10 represents the best experience.
Not Provided
Not Provided
 
Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy
Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy
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.

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."

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Barrett's Esophagus
  • Device: EG Scan II (transnasal endoscopy)
  • Procedure: Standard Endoscopy
  • Active Comparator: Subjects with Barrett's Esophagus
    All subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy.
    Interventions:
    • 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.
    Interventions:
    • Device: EG Scan II (transnasal endoscopy)
    • Procedure: Standard Endoscopy
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. 2018 Aug 3. pii: S1542-3565(18)30743-2. doi: 10.1016/j.cgh.2018.07.019. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Same as current
March 2016
October 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02066233
13-008214
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
Plan to Share IPD: No
Prasad G. Iyer, Mayo Clinic
Mayo Clinic
IntroMedic Co., Ltd.
Principal Investigator: Prasad G Iyer, MD Mayo Clinic
Mayo Clinic
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP