Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator

Обзор

The REALITY study is a prospective, post-market, non-randomized, multi-center, single-arm, open-label study intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott's neurostimulation systems.

Подробное описание

This study has broad inclusion criteria and minimal exclusion criteria to ensure the results are representative of the real-world use of these devices. Enrollment caps will be implemented to ensure patients from approved indications are represented. Individuals who are scheduled to receive an implantable Abbott neurostimulation system are eligible for study consideration. The study will enroll up to 2,000 subjects from up to 100 participating centers. Subject enrollment is expected to be completed within 7 years; subjects will be followed for 5 years. The total duration of the study is expected to be 13 years, including enrollment, data collection from all subjects, and study close out.

Вмешательства

• Устройство Spinal cord stimulation (SCS)
  Subjects will be implanted with market-released Abbott SCS systems
• Устройство Dorsal root ganglion stimulation (DRG)
  Subjects will be implanted with market-released Abbott DRG system

Первичные конечные точки

• Rate of device and procedure related adverse events, deaths, and device deficiencies [Срок оценки: Baseline]
• Rate of device and procedure related adverse events, deaths, and device deficiencies [Срок оценки: Permanent Implant Procedure]
• Rate of device and procedure related adverse events, deaths, and device deficiencies [Срок оценки: 6 months]
• Rate of device and procedure related adverse events, deaths, and device deficiencies [Срок оценки: 9 months]
• Rate of device and procedure related adverse events, deaths, and device deficiencies [Срок оценки: 1 Year]
• Rate of device and procedure related adverse events, deaths, and device deficiencies [Срок оценки: 1.5 Years]
• Rate of device and procedure related adverse events, deaths, and device deficiencies [Срок оценки: 2 Years]
• Rate of device and procedure related adverse events, deaths, and device deficiencies [Срок оценки: 2.5 Years]
• Rate of device and procedure related adverse events, deaths, and device deficiencies [Срок оценки: 3 Years]
• Rate of device and procedure related adverse events, deaths, and device deficiencies [Срок оценки: 3.5 Years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 30 центров

• Phoenician Centers for Research & Innovation — Phoenix
• Pain Institute of Southern Arizona — Tucson
• California Orthopedics & Spine — Larkspur
• Restore Orthopedics & Spine Center — Orange
• Foothills Pain Management Clinic — Pomona
• Pacific Research Institute — Santa Rosa
• University of Florida Department of Anesthesia — Gainesville
• Rush University Medical Center — Chicago
• … и ещё 22 центра

Германия · 9 центров

• Universitäts Klinikum Tübingen — Tübingen
• Klinikum Ingolstadt GmbH — Ingolstadt
• Krankenhaus Porz am Rhein — Cologne
• Klinikum Duisburg GmbH — Duisburg
• Universitaetsklinikum Duesseldorf — Düsseldorf
• Krankenhaus Neuwerk Maria von den Aposteln — Mönchengladbach
• Kliniken der Stadt Köln-Merheim — Cologne
• Universitätsklinikum Schleswig-Holstein — Lübeck
• … и ещё 1 центр

Великобритания · 4 центра

• Norfolk and Norwich Hospital — Norwich
• The Walton Centre — Liverpool
• Southmead Hospital — Bristol
• Seacroft Hospital — Leeds

Испания · 3 центра

• Hospital Universitario de Salamanca — Salamanca
• Hospital Universitario Puerta de Hierro — Majadahonda
• Hospital Universitari i Politècnic La Fe — Valencia

Австралия · 2 центра

• Metro Pain Group — Clayton
• Precision Brain, Spine & Pain Centre — Kew

Бельгия · 2 центра

• AZ Nikolaas — Sint-Niklaas
• AZ Delta vzw — Roeselare

Италия · 2 центра

• Azienda Ospedaliera Monaldi — Naples
• Fondazione Salvatore Maugeri — Pavia

Нидерланды · 2 центра

• Erasmus MC — Rotterdam
• St. Antonius Ziekenhuis — Nieuwegein

Швейцария · 1 центр

• Hôpital du Valais — Sion

Идентификаторы

NCT: NCT03876054 · ABT-CIP-10279

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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