To confirm performance of the Captivator™ EMR device for resection of early neoplasia in Barrett's Esophagus.
Study Type
OBSERVATIONAL
Enrollment
291
The Captivator ™ EMR Device is indicated for endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract.
Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
University Hospital Leuven
Leuven, Belgium
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
Time frame: Procedure
Number of resections per procedure
The number of resection per procedure is assessed during the EMR Procedure
Time frame: Procedure
Total procedure time
Total procedure time is assessed during the EMR procedure
Time frame: Procedure
Seriousness and severity of adverse events related to the Captivator™ 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: * Immediately following the EMR procedure (Post procedure evaluation) * 48 hour telephone call * 30 day telephone call * Unscheduled clinic visits will be performed in-between protocol required follow-up, as necessary. Once the 30 day phone call is complete, the subject will have completed the study.
Time frame: 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
Time frame: Procedure
Ability to endoscopically manage complications without the need for additional interventions
Endoscopic management of complications is assessed during the EMR procedure
Time frame: Procedure
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St. Michael's Hospital
Toronto, Ontario, Canada
Krankenhaus Barmherzige Bruder
Regensburg, Bavaria, Germany
EVK Krankenhaus
Düsseldorf, Germany
Academic Medical Center
Amsterdam, AZ, Netherlands
Catharina Hospital
Eindhoven, EJ, Netherlands
St. Antonius Hospital
Nieuwgein, NL, Netherlands
Erasmus MC - University Medical Center
Rotterdam, Netherlands
...and 3 more locations
Accessory devices used to complete the resection procedure
Accessory devices used to complete resection is assessed during the EMR procedure
Time frame: 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.
Time frame: Post Procedure