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This is a multi-center, prospective, randomized study which will enroll patients undergoing endoscopic surveillance due to a history of histologically confirmed dysplasia. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Barrett's associated esophageal dysplasia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Test | Procedure | WATS3D brush biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of Barrett's associated high grade esophageal dysplasia and esophageal adenocarcinoma (HGD/EAC) using WATS3D and random 4 quadrant forceps biopsies taken at 2 cm intervals. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Barrett's related dysplasia and adenocarcinoma diagnosed with random forceps biopsies and WATS3D biopsies used in alternating fashion. | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Barrett's associated esophageal dysplasia
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| Name | Affiliation | Role |
|---|---|---|
| Raf Bisschops, MD | University Hospitals Leuven, Dept. of Gastroenterology | Principal Investigator |
| Cesare Hassan, MD | Nuovo Regina Margherita Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven - Campus Gasthuisberg | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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