EndoMAXX EVT Compared to EndoMAXX

Overview

Información sobre este estudio

This is a prospective, single blinded, randomized study of EndoMAXX EVT Fully Covered Esophageal Stent with Valve for the treatment of malignant strictures of the lower esophagus. The purpose of this study is to evaluate improvement of dysphagia due to esophageal stricture with EndoMAXX EVT Fully Covered Esophageal Stent with Valve (investigational device) compared to the EndoMAXX Fully Covered Esophageal Stent (reference device).

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:

  1. Patient is 18 years of age or older
  2. Patient (or legal representative) is able to understand and provide signed informed consent
  3. Patient has a malignant stricture of the distal esophagus or gastric cardia requiring stent placement across the gastroesophageal junction.

Exclusion Criteria:

  1. Patient is unwilling or unable to comply with the follow-up schedule
  2. Patient is contraindicated for endoscopic procedure for any reason
  3. Patient presents with esophagorespiratory fistula
  4. Patient has previously undergone esophageal stenting or esophagectomy
  5. Female patient is pregnant, breastfeeding, or premenopausal and not using an effective method of contraception
  6. Patient's esophageal tumor length exceeds that which can be treated with a single stent (maximum lesion length 9.5cm)
  7. Removal of stent is scheduled to occur within six months
  8. Patient has trouble swallowing or experiences regurgitation for reasons which are not related to his/her esophageal cancer
  9. Any other factor identified by the Investigator that would disqualify the prospective patient from participation in the study including but not limited to coagulative disorders and anesthetic risk.

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

Louis Wong Kee Song, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20143162

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