The Captivator EMR Registry

NCT02482701 | Completed

• 1 other identifier: 91038126
• Study Type: observational
• Target: 291
• Locations: 6 countries
• Sites: 13

Brief Summary

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

Conditions

Barrett's Esophagus

Keywords

EMR; EAC; Barrett's Neoplasia; Multiband Mucosectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of resections per procedure

  Procedure

• Total procedure time

  Procedure

• Seriousness and severity of adverse events related to the Captivator™ EMR device or procedure

  Procedure through 30 days post EMR procedure

• Accessory devices used during the procedure for complication management

  Procedure

• Ability to endoscopically manage complications without the need for additional interventions

  Procedure

Interventions

Captivator™ EMR DEVICE

The Captivator ™ EMR Device is indicated for endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Barrett's Esophagus patients with early neoplasia.

You may qualify if:

• 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:
• 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.
• 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.

You may not qualify if:

• 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.
• Presence of esophageal stenosis preventing passage of a therapeutic gastroscope.
• Endoscopically visible scarring by any cause of the intended treatment zone.
• Esophageal varices.
• Subject has known or suspected esophageal perforation.
• Coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed).

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (13)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University Hospital Leuven

Leuven, 3000, Belgium

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Krankenhaus Barmherzige Bruder

Regensburg, Bavaria, 93049, Germany

Location

EVK Krankenhaus

Düsseldorf, D-40217, Germany

Location

Academic Medical Center

Amsterdam, AZ, 1105, Netherlands

Location

Catharina Hospital

Eindhoven, EJ, 5623, Netherlands

Location

St. Antonius Hospital

Nieuwgein, NL, 3435CM, Netherlands

Location

Erasmus MC - University Medical Center

Rotterdam, 3015CE, Netherlands

Location

Addenbrookes Hospital

Cambridge, Cambridgeshire, CB20QQ, United Kingdom

Location

University College Hospital

London, NW1 2BU, United Kingdom

Location

Nottingham Digestive Disease Centre, NIHR

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30220300 DERIVED

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jacques Bergman, MD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 26, 2015
• Study Start: August 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

BE (1); CA (1); US (2); NL (4); GB (3); DE (2)