The Captivator EMR Registry

An International, Multicenter, Prospective, Post Market Registry Using a New Device for Endoscopic Resection of Early Neoplasia in Barrett's Esophagus

To confirm performance of the Captivator™ EMR device for resection of early neoplasia in Barrett's Esophagus.

Study Overview

• Status: Completed
• Conditions: Barrett's Esophagus
• Intervention / Treatment: Device: Captivator™ EMR

• Study Type: Observational
• Enrollment (Actual): 291

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospital Leuven
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
• Germany
  • Dusseldorf, Germany, D-40217
    • EVK Krankenhaus
  • Bavaria
    • Regensburg, Bavaria, Germany, 93049
      • Krankenhaus Barmherzige Brüder
• Netherlands
  • Rotterdam, Netherlands, 3015CE
    • Erasmus MC - University Medical Center
  • AZ
    • Amsterdam, AZ, Netherlands, 1105
      • Academic Medical Center
  • EJ
    • Eindhoven, EJ, Netherlands, 5623
      • Catharina Hospital
  • NL
    • Nieuwgein, NL, Netherlands, 3435CM
      • St. Antonius Hospital
• United Kingdom
  • London, United Kingdom, NW1 2BU
    • University College Hospital
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham Digestive Disease Centre, NIHR
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB20QQ
      • Addenbrookes Hospital
• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Barrett's Esophagus patients with early neoplasia.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.	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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Jacques Bergman, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 15, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (Estimate): June 26, 2015

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: EMR; EAC; Barrett's Neoplasia; Multiband Mucosectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: 91038126