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Pretest of Alfapump® Patient Preference Discrete-choice Experiment

Overview

Información sobre este estudio

The overall objective of the patient preference evaluation is to understand how patients tradeoff the benefits and risks of the alfapump related to the primary endpoints of the current POSEIDON clinical trial in support of future marketing application.

The alfapump system is designed to reduce or eliminate the need for therapeutic paracentesis and to provide relief from symptoms of tense ascites with its attendant effects on patient quality of life (QOL) and nutrition. fits and risks of the alfapump related to the primary endpoints of the current POSEIDON clinical trial in support of future marketing application.

 

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:

  • Male and female patients, ≥ 18 years of age
  • Cirrhosis of liver defined by histological and/or clinical, endoscopic, laboratory and radiological criteria.
  • Refractory or recurrent ascites primarily managed with periodic therapeutic paracentesis.
  • Not a candidate for (refused, contraindicated) TIPS or previously implanted TIPS is permanently obstructed or non-functioning.
  • Life expectancy of at least 6 months.
  • Capable of giving written informed consent and able to understand and complete the survey in English.

Exclusion Criteria:

  • Patients that have lost the ability to understand the meaning or importance of something and the ability to talk or write, resulting in the inability to live independently.

Therapeutic Paracentesis is defined as removal of at least 1.5L of ascitic fluid by means of percutaneous drainage with therapeutic intent in patients with symptoms related to fluid accumulation or clear evidence of ascites accumulation (weight gain, abdominal circumference), excluding patients receiving a puncture for diagnostic purpose only.

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

Patrick Kamath, M.D.

Cerrado para la inscripción

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Hugo Vargas, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20516791

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