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enrollment moved very slowly which was not anticipated, and, funding issues
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| Name | Class |
|---|---|
| Olympus | INDUSTRY |
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The investigators seek to test the hypothesis that the improved version of high definition white light endoscopes and Narrow Band Imaging (NBI) are more accurate in detecting residual Barrett's Metaplasia and Dysplasia disease after previous resection or ablation treatments than current versions of these endoscopes.
Information will be collected. Images will be taken.
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Agreement Between Imaging and Histology | The accuracy of agreement between endoscopic imaging diagnosis compared with biopsy histology diagnosis. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Residual Disease | Presence of any residual Barrett's disease at follow-up endoscopy after ablation / resection treatment. | 9 months |
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Inclusion Criteria:
Deferral Criteria: This category is for patients in two specific situations, 1) Erosive esophagitis, and, 2) presence of a nodule suspicious for the presence of neoplasia.
Note: Only one deferral per patient is permitted, and this one deferral is allowed only for these specific criteria. The end of the study will be defined by the time of follow-up of the last patient who was not deferred; any deferred patients who have not completed follow-up procedures by that time, may miss their follow-up visit as part of the study. (This is to prevent the possibility of delaying the close of the study due to deferral of a procedure late in the study.)
Exclusion Criteria:
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Men and women (not pregnant) presenting to the GI Lab for Upper Endoscopy. Child-bearing potential not excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Herbert C. Wolfsen,, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | 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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| D004066 |
| Digestive System Diseases |