An interventional study of EG Scan II (transnasal endoscopy) and Standard Endoscopy in Barrett's Esophagus, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-06.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic
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."
310 studies on the registry are indexed under Barrett Esophagus; 64 are open to participants now.
This study's enrollment of 100 is above the median of 62 across 186 interventional studies indexed under Barrett Esophagus.
Browse Barrett Esophagus studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Exclusion Criteria:
All subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy.
Device: EG Scan II (transnasal endoscopy) · Procedure: Standard Endoscopy
All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.
Device: EG Scan II (transnasal endoscopy) · Procedure: Standard Endoscopy
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
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
| Milestone | Subjects With Barrett's Esophagus | Subjects With Reflux and/or Heartburn |
|---|---|---|
| Started | 50 | 50 |
| Completed | 44 | 44 |
| Not completed | 6 | 6 |
| Withdrew: Difficulty intubating subject | 6 | 6 |
| Milestone | Subjects With Barrett's Esophagus | Subjects With Reflux and/or Heartburn |
|---|---|---|
| Started | 44 | 44 |
| Completed | 44 | 44 |
| Not completed | 0 | 0 |
On the 10-point VAS, 0 represented the "worst experience" and 10 the "best experience."
| units on a scale | Subjects With Barrett's Esophagus | Subjects With Reflux and/or Heartburn |
|---|---|---|
| EG II Scan | 7 (3 to 10) | 8 (1 to 10) |
| Standard Endoscopy | 8 (4 to 10) | 8 (2 to 10) |
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.
| Participants | Subjects With Barrett's Esophagus | Subjects With Reflux and/or Heartburn |
|---|---|---|
| Nasal Camera Test | 21 | 18 |
| Oral Camera Test | 4 | 11 |
| Either Test | 17 | 15 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects With Barrett's Esophagus | 0/44 (0%) | 0/44 (0%) | 44/44 (100%) |
| Subjects With Reflux and/or Heartburn | 0/44 (0%) | 0/44 (0%) | 44/44 (100%) |
| Event | Subjects With Barrett's Esophagus | Subjects With Reflux and/or Heartburn |
|---|---|---|
| DiscomfortGeneral disorders | 38/44 | 43/44 |
| Gagging/RetchingGastrointestinal disorders | 32/44 | 36/44 |
| Nasal PainRespiratory, thoracic and mediastinal disorders | 27/44 | 34/44 |
| ChokingGastrointestinal disorders | 21/44 | 12/44 |
| Nose BleedRespiratory, thoracic and mediastinal disorders | 1/44 | 0/44 |
| Age, Continuous(years) | Subjects With Barrett's Esophagus | Subjects With Reflux and/or Heartburn | Total |
|---|---|---|---|
| Mean | 60.66 ± 11.62 | 51.72 ± 15.07 | 56.19 ± 14.12 |
| Sex: Female, Male(Participants) | Subjects With Barrett's Esophagus | Subjects With Reflux and/or Heartburn | Total |
|---|---|---|---|
| Female | 9 | 20 | 29 |
| Male | 41 | 30 | 71 |
| Region of Enrollment(Participants) | Subjects With Barrett's Esophagus | Subjects With Reflux and/or Heartburn | Total |
|---|---|---|---|
| United States | 50 | 50 | 100 |
Plan to share: No
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