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Using a non-invasive capsule system to achieve optimal viewing angles of the esophagus for detection of Barrett's esophagus
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long Segment Barrett's Esophagus (LSBE) | Experimental | Subjects diagnosed with Long Segment Barrett's Esophagus (LSBE) |
|
| Short Segment Barrett's Esophagus (SSBE) | Experimental | Subjects diagnosed with Short Segment Barrett's Esophagus (SSBE) |
|
| Gastro Esophageal Reflux Disease | Experimental | Subjects with Gastro Esophageal Reflux Disease (GERD) who are eligible for Barrett's Esophagus screening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaviCam Detachable String Capsule | Device | Subjects will swallow the NaviCam capsule with 20 ml water while positioned in the upright position. Once the capsule reaches the gastric cardia, the string will slowly be pulled up to systematically inspect the Z-line and upper, middle, and lower thirds of the esophagus guided by real-time viewing and by moving the capsule solely with the tether. Images will be captured at a rate of 2 frames per second. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of Columnar lined epithelium in the esophagus | Detection of Columnar lined epithelium in the esophagus | From start of procedure to removal of capsule, assessed up to 30 minutes timeframe from start to end of procedure.. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | Visual Analogue Scale (VAS) is an 11-tem questionnaire assessing pain, where 0 represents the "worst experience" and 10 the "best experience". Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain. | 30 minutes post-procedure |
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Inclusion Criteria
Adults greater than or equal to 22 years of age with or without Barrett's Esophagus
All Patients:
o Have had an endoscopy within 1 year of baseline enrollment
Patients with Barrett's Esophagus:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie McNew | Contact | 904-953-5080 | McNew.Stephanie@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Swathi Eluri | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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|
| Spielberger State-Trait Anxiety Inventory (STAI-6) |
Patient anxiety will be measured using the shorter 6 item form of the Spielberger State-Trait Anxiety Inventory (STAI-6), with a score over 40 as a threshold for clinically significant anxiety |
| Baseline, 30 minutes post-procedure |
| Impact of Events Scale (IES) | The Impact of Events Scale (IES) will be used to assess distress associated with the procedure and procedure acceptability. The IES is rated on a scale of 0 (not at all) to 4 (extremely), with higher scores indicating a greater level of distress. | Baseline, 7 days post-procedure |
| D004066 |
| Digestive System Diseases |