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A Study to Determine the Long-Term Real-World Outcomes on Patients Implanted With a Neurostimulator

Overview

Información sobre este estudio

The study is being conducted to gain a broader understanding of how Abbott’s neurostimulation systems are being used in the real-world setting. It will serve the dual purpose of collecting long-term safety and effectiveness of these devices and obtaining information about the different patient populations who are using them.

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:

  • Subject must provide written informed consent prior to any clinical investigation related procedure.
  • Subject is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment.
  • Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.
  • Subject has a baseline (with no stimulation) pain NRS of ≥ 6.

Exclusion Criteria:

  • Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator’s opinion, could limit the subject’s ability to participate in the clinical investigation or to comply with follow-up requirements.
  • Subject has or is scheduled to receive an intrathecal pump.
  • Subject is part of a vulnerable population.
  • Subject has an existing implanted neuromodulation device to address their chronic pain.

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

Oludare Olatoye, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20508590

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