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Completed

NCT Number: NCT02482701

The Captivator EMR Registry

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

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Leuven, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Captivator™ EMR

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 26, 2015
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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