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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Subjects With Barrett's Esophagus All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Subjects With Reflux and/or Heartburn All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.

Participant Flow for 2 periods

Period 1:   EG Scan II (Day 1)
    Subjects With Barrett's Esophagus   Subjects With Reflux and/or Heartburn
STARTED   50   50 
COMPLETED   44   44 
NOT COMPLETED   6   6 
difficulty intubating subject                6                6 

Period 2:   Standard Endoscopy (Day 2)
    Subjects With Barrett's Esophagus   Subjects With Reflux and/or Heartburn
STARTED   44   44 
COMPLETED   44   44 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Subjects With Barrett's Esophagus All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Subjects With Reflux and/or Heartburn All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Total Total of all reporting groups

Baseline Measures
   Subjects With Barrett's Esophagus   Subjects With Reflux and/or Heartburn   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   50   100 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.66  (11.62)   51.72  (15.07)   56.19  (14.12) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  18.0%      20  40.0%      29  29.0% 
Male      41  82.0%      30  60.0%      71  71.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   50   50   100 


  Outcome Measures

1.  Primary:   Median Tolerability Score on 10-point Visual Analog Scale (VAS)   [ Time Frame: Within 48 hours ]

2.  Secondary:   Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy   [ Time Frame: Two weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: Iyer.Prasad@mayo.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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