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To confirm performance of the Captivatorâ„¢ EMR device for resection of early neoplasia in Barrett's Esophagus.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Captivatorâ„¢ EMR | Device | The Captivator â„¢ EMR Device is indicated for endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful endoscopic resection defined as complete resection of the delineated area, including all delineation markings, in a single procedure. | Successful resection is assessed during the EMR procedure | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of resections per procedure | The number of resection per procedure is assessed during the EMR Procedure | Procedure |
| Total procedure time | Total procedure time is assessed during the EMR procedure |
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Inclusion Criteria:
Age 18-80 years.
Barrett's esophagus with a visible abnormality confirmed upon prior endoscopy. A visible abnormality is described as meeting one or more of the following definitions:
Subject is scheduled for endoscopic resection of present neoplasia
Subject is amenable to EMR with no suspicion of submucosal invasion, based on the macroscopic appearance and/or endosonography upon earlier endoscopy.
Subject is taking PPI (Proton Pump Inhibitor) BID (Twice Daily) 40 mg (or equivalent dosage).
Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.
Exclusion Criteria:
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Barrett's Esophagus patients with early neoplasia.
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Bergman, MD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30220300 | Derived | Pouw RE, Beyna T, Belghazi K, Koch AD, Schoon EJ, Haidry R, Weusten BL, Bisschops R, Shaheen NJ, Wallace MB, Marcon N, Heise-Ginsburg R, Gotink AW, Wang KK, Leggett CL, Ortiz-Fernandez-Sordo J, Ragunath K, DiPietro M, Pech O, Neuhaus H, Bergman JJ. A prospective multicenter study using a new multiband mucosectomy device for endoscopic resection of early neoplasia in Barrett's esophagus. Gastrointest Endosc. 2018 Oct;88(4):647-654. doi: 10.1016/j.gie.2018.06.030. Epub 2018 Jul 6. |
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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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| Procedure |
| Seriousness and severity of adverse events related to the Captivatorâ„¢ EMR device or procedure | Study subjects will have follow-up visits after the EMR procedure during which the occurrence of adverse events related to the Captivator EMR procedure or device will be assessed. These visits will occur at the following time points:
Once the 30 day phone call is complete, the subject will have completed the study. | Procedure through 30 days post EMR procedure |
| Accessory devices used during the procedure for complication management | Accessory device use is assessed during the EMR procedure | Procedure |
| Ability to endoscopically manage complications without the need for additional interventions | Endoscopic management of complications is assessed during the EMR procedure | Procedure |
| Accessory devices used to complete the resection procedure | Accessory devices used to complete resection is assessed during the EMR procedure | Procedure |
| Histopathology | Histopathology of resection specimens is performed per standard of practice at each participating study center. Results are expected within approximately 7 days of the EMR procedure. | Post Procedure |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| University Hospital Leuven | Leuven | 3000 | Belgium |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Krankenhaus Barmherzige Bruder | Regensburg | Bavaria | 93049 | Germany |
| EVK Krankenhaus | Düsseldorf | D-40217 | Germany |
| Academic Medical Center | Amsterdam | AZ | 1105 | Netherlands |
| Catharina Hospital | Eindhoven | EJ | 5623 | Netherlands |
| St. Antonius Hospital | Nieuwgein | NL | 3435CM | Netherlands |
| Erasmus MC - University Medical Center | Rotterdam | 3015CE | Netherlands |
| Addenbrookes Hospital | Cambridge | Cambridgeshire | CB20QQ | United Kingdom |
| University College Hospital | London | NW1 2BU | United Kingdom |
| Nottingham Digestive Disease Centre, NIHR | Nottingham | NG7 2UH | United Kingdom |
| D004066 |
| Digestive System Diseases |