A Study to Evaluate the Feasibility of NvisionVLE® Imaging System Capsule Probe

Overview

Información sobre este estudio

The purpose of this study is to determine the feasibility and tolerability of obtaining esophageal VLE images using the NvisionVLE® Imaging System Capsule Probe.

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:

  • Males and females.
  • 18 years of age or older.
  • Treatment naive patient who is under BE surveillance or is presenting for dysplasia confirmation or initial treatment.
  • Patient is able and willing to provide written informed consent.
  • Patient has fasted per institutional guidelines.

Exclusion Criteria:

  • Significant esophageal fistula or stricture requiring dilation.
  • Symptoms of dysphagia.
  • Suspicion or known history of gastrointestinal obstruction or mass, varices, rings or webs.
  • Known tortuous esophageal/GEJ anatomy.
  • Any prior esophageal treatment (e.g., ablation, dilation, surgery, etc.).
  • Known inability to swallow pills and capsules, or history of a swallowing disorder (e.g., odynophagia, scleroderma, achalasia, esophageal stricture, or esophageal diverticulum.
  • Current diagnosis of cancer.
  • Patients for whom use of the Nvision VLE device would be in conflict with the Instructions for Use (IFU).
  • Other major medical illnesses (e.g., unstable cardiovascular disease, end-stage liver or kidney disease, recent or suspected active GI bleeding).
  • Patients who require anticoagulants.
  • Patients who are known to be pregnant.
  • Patients who are enrolled in a competing clinincal study.
  • Patients for whom the physician feels would not be a good candidate to participate (physician discretion).

 

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

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Francisco Ramirez, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20482093

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