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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Barrett's Esophagus
Interventions Device: EG Scan II (transnasal endoscopy)
Procedure: Standard Endoscopy
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Subjects With Barrett's Esophagus Subjects With Reflux and/or Heartburn
Hide Arm/Group Description All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Period Title: EG Scan II (Day 1)
Started 50 50
Completed 44 44
Not Completed 6 6
Reason Not Completed
difficulty intubating subject             6             6
Period Title: Standard Endoscopy (Day 2)
Started 44 44
Completed 44 44
Not Completed 0 0
Arm/Group Title Subjects With Barrett's Esophagus Subjects With Reflux and/or Heartburn Total
Hide Arm/Group Description All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
60.66  (11.62) 51.72  (15.07) 56.19  (14.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
9
  18.0%
20
  40.0%
29
  29.0%
Male
41
  82.0%
30
  60.0%
71
  71.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 50 participants 50 participants 100 participants
50
 100.0%
50
 100.0%
100
 100.0%
1.Primary Outcome
Title Median Tolerability Score on 10-point Visual Analog Scale (VAS)
Hide Description On the 10-point VAS, 0 represented the "worst experience" and 10 the "best experience."
Time Frame Within 48 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subjects With Barrett's Esophagus Subjects With Reflux and/or Heartburn
Hide Arm/Group Description:
All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Overall Number of Participants Analyzed 44 44
Median (Full Range)
Unit of Measure: units on a scale
EG II Scan
7
(3 to 10)
8
(1 to 10)
Standard Endoscopy
8
(4 to 10)
8
(2 to 10)
2.Secondary Outcome
Title Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects on the reflux and/or heartburn arm didn't answer this question.
Arm/Group Title Subjects With Barrett's Esophagus Subjects With Reflux and/or Heartburn
Hide Arm/Group Description:
All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Overall Number of Participants Analyzed 42 44
Measure Type: Count of Participants
Unit of Measure: Participants
Nasal Camera Test
21
  50.0%
18
  40.9%
Oral Camera Test
4
   9.5%
11
  25.0%
Either Test
17
  40.5%
15
  34.1%
Time Frame 2 weeks
Adverse Event Reporting Description Presenting adverse events per per intervention was not possible, as most patients were sedated prior to the procedures and only a few were not sedated. Therefore the adverse events were per patient population (study arm).
 
Arm/Group Title Subjects With Barrett's Esophagus Subjects With Reflux and/or Heartburn
Hide Arm/Group Description All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
All-Cause Mortality
Subjects With Barrett's Esophagus Subjects With Reflux and/or Heartburn
Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)      0/44 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Subjects With Barrett's Esophagus Subjects With Reflux and/or Heartburn
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/44 (0.00%)      0/44 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subjects With Barrett's Esophagus Subjects With Reflux and/or Heartburn
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/44 (100.00%)      44/44 (100.00%)    
Gastrointestinal disorders     
Gagging/Retching   32/44 (72.73%)  32 36/44 (81.82%)  36
Choking   21/44 (47.73%)  21 12/44 (27.27%)  12
General disorders     
Discomfort   38/44 (86.36%)  38 43/44 (97.73%)  43
Respiratory, thoracic and mediastinal disorders     
Nasal Pain   27/44 (61.36%)  27 34/44 (77.27%)  34
Nose Bleed   1/44 (2.27%)  1 0/44 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Prasad G. Iyer
Organization: Mayo Clinic
Phone: 507-284-6469
Responsible Party: Prasad G. Iyer, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02066233     History of Changes
Other Study ID Numbers: 13-008214
First Submitted: February 3, 2014
First Posted: February 19, 2014
Results First Submitted: May 1, 2017
Results First Posted: July 6, 2017
Last Update Posted: July 6, 2017