Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
291 participants
OBSERVATIONAL
2015-08-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Captivator™ EMR
The Captivator ™ EMR Device is indicated for endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract.
Eligibility Criteria
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Inclusion Criteria
2. 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:
* Lesion is detected as visible based on white light imaging with any macroscopic appearance according to the Paris Classification and is also endoscopically resectable.
* Lesion is detected by narrow band imaging (NBI), but without any other specific characteristics for a visible lesion.
* Lesion is confirmed to contain high grade dysplasia and/or carcinoma upon prior biopsy.
3. Subject is scheduled for endoscopic resection of present neoplasia
4. Subject is amenable to EMR with no suspicion of submucosal invasion, based on the macroscopic appearance and/or endosonography upon earlier endoscopy.
5. Subject is taking PPI (Proton Pump Inhibitor) BID (Twice Daily) 40 mg (or equivalent dosage).
6. Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.
Exclusion Criteria
2. Presence of esophageal stenosis preventing passage of a therapeutic gastroscope.
3. Endoscopically visible scarring by any cause of the intended treatment zone.
4. Esophageal varices.
5. Subject has known or suspected esophageal perforation.
6. Coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed).
18 Years
80 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jacques Bergman, MD
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
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Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
University Hospital Leuven
Leuven, , Belgium
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
Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom
University College Hospital
London, , United Kingdom
Nottingham Digestive Disease Centre, NIHR
Nottingham, , United Kingdom
Countries
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References
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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.
Other Identifiers
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91038126
Identifier Type: -
Identifier Source: org_study_id
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