The Captivator EMR Registry

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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)

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Cadman Leggett, M.D.

Cerrado para la inscripción

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Herbert Wolfsen, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20491135

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