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| Name | Class |
|---|---|
| IntroMedic Co., Ltd. | INDUSTRY |
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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. Scanâ„¢ 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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Barrett's Esophagus | Active Comparator | All subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy. |
|
| Subjects with Reflux and/or Heartburn | Active Comparator | All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EG Scan II (transnasal endoscopy) | Device |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Within 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prasad G Iyer, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30081223 | Derived | Sami SS, Iyer PG, Pophali P, Halland M, di Pietro M, Ortiz-Fernandez-Sordo J, White JR, Johnson M, Guha IN, Fitzgerald RC, Ragunath K. Acceptability, Accuracy, and Safety of Disposable Transnasal Capsule Endoscopy for Barrett's Esophagus Screening. Clin Gastroenterol Hepatol. 2019 Mar;17(4):638-646.e1. doi: 10.1016/j.cgh.2018.07.019. Epub 2018 Aug 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With Barrett's Esophagus | All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. |
| FG001 | Subjects With Reflux and/or Heartburn | All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EG Scan II (Day 1) |
|
| ||||||||||||||||||
| Standard Endoscopy (Day 2) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Barrett's Esophagus | All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. |
| BG001 | Subjects With Reflux and/or Heartburn | All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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." | Posted | Median | Full Range | units on a scale | Within 48 hours |
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With Barrett's Esophagus | All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gagging/Retching | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Prasad G. Iyer | Mayo Clinic | 507-284-6469 | Iyer.Prasad@mayo.edu |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D005764 | Gastroesophageal Reflux |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Standard Endoscopy |
| Procedure |
|
| Two weeks |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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. | Two subjects on the reflux and/or heartburn arm didn't answer this question. | Posted | Count of Participants | Participants | Two weeks |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 44 |
| 44 |
| EG001 | Subjects With Reflux and/or Heartburn | All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. | 0 | 44 | 0 | 44 | 44 | 44 |
| Choking | Gastrointestinal disorders | Systematic Assessment |
|
| Discomfort | General disorders | Systematic Assessment |
|
| Nasal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nose Bleed | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Either Test |
|