Barrett's Esophagus
Conditions
Keywords
Barrett's, esophagus, reflux, heartburn, screening
Brief summary
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.
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.
Interventions
DEVICEEG Scan II (transnasal endoscopy)
PROCEDUREStandard Endoscopy
Sponsors
IntroMedic Co., Ltd.
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Tolerability Score on 10-point Visual Analog Scale (VAS) | Within 48 hours | On the 10-point VAS, 0 represented the worst experience and 10 the best experience. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Barrett's Esophagus All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. | 50 |
| Subjects With Reflux and/or Heartburn All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| EG Scan II (Day 1) | difficulty intubating subject | 6 | 6 |
Baseline characteristics
| Characteristic | Subjects With Barrett's Esophagus | Subjects With Reflux and/or Heartburn | Total |
|---|---|---|---|
| Age, Continuous | 60.66 years STANDARD_DEVIATION 11.62 | 51.72 years STANDARD_DEVIATION 15.07 | 56.19 years STANDARD_DEVIATION 14.12 |
| Region of Enrollment United States | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Female | 9 Participants | 20 Participants | 29 Participants |
| Sex: Female, Male Male | 41 Participants | 30 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 44 |
| other Total, other adverse events | 44 / 44 | 44 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
Primary
Median Tolerability Score on 10-point Visual Analog Scale (VAS)
On the 10-point VAS, 0 represented the worst experience and 10 the best experience.
Time frame: Within 48 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects With Barrett's Esophagus | Median Tolerability Score on 10-point Visual Analog Scale (VAS) | EG II Scan | 7 units on a scale |
| Subjects With Barrett's Esophagus | Median Tolerability Score on 10-point Visual Analog Scale (VAS) | Standard Endoscopy | 8 units on a scale |
| Subjects With Reflux and/or Heartburn | Median Tolerability Score on 10-point Visual Analog Scale (VAS) | Standard Endoscopy | 8 units on a scale |
| Subjects With Reflux and/or Heartburn | Median Tolerability Score on 10-point Visual Analog Scale (VAS) | EG II Scan | 8 units on a scale |
Secondary
Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy
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
Population: Two subjects on the reflux and/or heartburn arm didn't answer this question.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With Barrett's Esophagus | Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy | Nasal Camera Test | 21 Participants |
| Subjects With Barrett's Esophagus | Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy | Oral Camera Test | 4 Participants |
| Subjects With Barrett's Esophagus | Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy | Either Test | 17 Participants |
| Subjects With Reflux and/or Heartburn | Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy | Nasal Camera Test | 18 Participants |
| Subjects With Reflux and/or Heartburn | Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy | Oral Camera Test | 11 Participants |
| Subjects With Reflux and/or Heartburn | Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy | Either Test | 15 Participants |