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The Captivator EMR Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02482701
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:
To confirm performance of the Captivator™ EMR device for resection of early neoplasia in Barrett's Esophagus.

Condition or disease Intervention/treatment
Barrett's Esophagus Device: Captivator™ EMR

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 291 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: An International, Multicenter, Prospective, Post Market Registry Using a New Device for Endoscopic Resection of Early Neoplasia in Barrett's Esophagus
Actual Study Start Date : August 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : June 2017
Groups and Cohorts
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Intervention Details:
  • Device: Captivator™ EMR
    The Captivator ™ EMR Device is indicated for endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract.

Outcome Measures
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Primary Outcome Measures :
  1. Successful endoscopic resection defined as complete resection of the delineated area, including all delineation markings, in a single procedure. [ Time Frame: Procedure ]
    Successful resection is assessed during the EMR procedure


Secondary Outcome Measures :
  1. Number of resections per procedure [ Time Frame: Procedure ]
    The number of resection per procedure is assessed during the EMR Procedure

  2. Total procedure time [ Time Frame: Procedure ]
    Total procedure time is assessed during the EMR procedure

  3. Seriousness and severity of adverse events related to the Captivator™ EMR device or procedure [ Time Frame: Procedure through 30 days post EMR 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.


  4. Accessory devices used during the procedure for complication management [ Time Frame: Procedure ]
    Accessory device use is assessed during the EMR procedure

  5. Ability to endoscopically manage complications without the need for additional interventions [ Time Frame: Procedure ]
    Endoscopic management of complications is assessed during the EMR procedure

  6. Accessory devices used to complete the resection procedure [ Time Frame: Procedure ]
    Accessory devices used to complete resection is assessed during the EMR procedure

  7. Histopathology [ Time Frame: Post Procedure ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Barrett's Esophagus patients with early neoplasia.
Criteria

Inclusion Criteria:

  1. Age 18-80 years.

  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:

  1. Subject has previously undergone endoscopic therapy for esophageal neoplasia, including (but not limited to) cryospray therapy, laser treatment, photodynamic therapy, endoscopic mucosal resection, radiofrequency ablation, argon plasma coagulation or radiotherapy.
  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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482701


Locations
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United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Belgium
University Hospital Leuven
Leuven, Belgium, 3000
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Germany
Krankenhaus Barmherzige Bruder
Regensburg, Bavaria, Germany, 93049
EVK Krankenhaus
Dusseldorf, Germany, D-40217
Netherlands
Academic Medical Center
Amsterdam, AZ, Netherlands, 1105
Catharina Hospital
Eindhoven, EJ, Netherlands, 5623
St. Antonius Hospital
Nieuwgein, NL, Netherlands, 3435CM
Erasmus MC - University Medical Center
Rotterdam, Netherlands, 3015CE
United Kingdom
Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom, CB20QQ
University College Hospital
London, United Kingdom, NW1 2BU
Nottingham Digestive Disease Centre, NIHR
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Jacques Bergman, MD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02482701    
Other Study ID Numbers: 91038126
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Keywords provided by Boston Scientific Corporation:
EMR
EAC
Barrett's Neoplasia
Multiband Mucosectomy
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases