The Captivator EMR Registry

Overview

About this study

The purpose of this study is to confirm the performance of the Captivator™ endoscopic mucosal resection device for resection of early tumor growth in Barrett's Esophagus.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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
  • Scheduled for endoscopic resection of present neoplasia
  • Amenable to Endoscopic Mucosal Resection with no suspicion of submucosal invasion, based on the macroscopic appearance and/or endosonography upon earlier endoscopy
  • Taking a proton pump inhibitor twice daily 40 mg or equivalent dosage
  • Willing to participate, fully understands the content of the informed consent form, and signs the informed consent form

Exclusion Criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Cadman Leggett, M.D.

Closed for enrollment

Jacksonville, Fla.

Mayo Clinic principal investigator

Herbert Wolfsen, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20491135

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