Trial Outcomes & Findings for Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy (NCT NCT02066233)

NCT ID: NCT02066233

Last Updated: 2017-07-06

Results Overview

On the 10-point VAS, 0 represented the "worst experience" and 10 the "best experience."

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: Within 48 hours
• Results posted on: 2017-07-06

Participant Flow

Participant milestones

Measure	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.
EG Scan II (Day 1) STARTED	50	50
EG Scan II (Day 1) COMPLETED	44	44
EG Scan II (Day 1) NOT COMPLETED	6	6
Standard Endoscopy (Day 2) STARTED	44	44
Standard Endoscopy (Day 2) COMPLETED	44	44
Standard Endoscopy (Day 2) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	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.
EG Scan II (Day 1) difficulty intubating subject	6	6

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Subjects With Barrett's Esophagus n=50 Participants All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.	Subjects With Reflux and/or Heartburn n=50 Participants All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.	Total n=100 Participants Total of all reporting groups
Age, Continuous	60.66 years STANDARD_DEVIATION 11.62 • n=5 Participants	51.72 years STANDARD_DEVIATION 15.07 • n=7 Participants	56.19 years STANDARD_DEVIATION 14.12 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	20 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	30 Participants n=7 Participants	71 Participants n=5 Participants
Region of Enrollment United States	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 48 hours

On the 10-point VAS, 0 represented the "worst experience" and 10 the "best experience."

Outcome measures

Measure	Subjects With Barrett's Esophagus n=44 Participants All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.	Subjects With Reflux and/or Heartburn n=44 Participants All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Median Tolerability Score on 10-point Visual Analog Scale (VAS) EG II Scan	7 units on a scale Interval 3.0 to 10.0	8 units on a scale Interval 1.0 to 10.0
Median Tolerability Score on 10-point Visual Analog Scale (VAS) Standard Endoscopy	8 units on a scale Interval 4.0 to 10.0	8 units on a scale Interval 2.0 to 10.0

SECONDARY outcome

Timeframe: Two weeks

Population: Two subjects on the reflux and/or heartburn arm didn't answer this question.

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.

Outcome measures

Measure	Subjects With Barrett's Esophagus n=42 Participants All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.	Subjects With Reflux and/or Heartburn n=44 Participants All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy Nasal Camera Test	21 Participants	18 Participants
Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy Oral Camera Test	4 Participants	11 Participants
Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy Either Test	17 Participants	15 Participants

Adverse Events

Subjects With Barrett's Esophagus

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Subjects With Reflux and/or Heartburn

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Subjects With Barrett's Esophagus n=44 participants at risk All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.	Subjects With Reflux and/or Heartburn n=44 participants at risk All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Gastrointestinal disorders Gagging/Retching	72.7% 32/44 • Number of events 32 • 2 weeks 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).	81.8% 36/44 • Number of events 36 • 2 weeks 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).
Gastrointestinal disorders Choking	47.7% 21/44 • Number of events 21 • 2 weeks 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).	27.3% 12/44 • Number of events 12 • 2 weeks 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).
General disorders Discomfort	86.4% 38/44 • Number of events 38 • 2 weeks 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).	97.7% 43/44 • Number of events 43 • 2 weeks 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).
Respiratory, thoracic and mediastinal disorders Nasal Pain	61.4% 27/44 • Number of events 27 • 2 weeks 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).	77.3% 34/44 • Number of events 34 • 2 weeks 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).
Respiratory, thoracic and mediastinal disorders Nose Bleed	2.3% 1/44 • Number of events 1 • 2 weeks 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).	0.00% 0/44 • 2 weeks 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).

Additional Information

Dr. Prasad G. Iyer

Mayo Clinic

Phone: 507-284-6469

Email: Iyer.Prasad@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place