RecruitingNCT06971796

EURO-STIM Registry

Longitudinal Outcomes and Adherence of the Inspire System, EURO-STIM Registry


Sponsor

Inspire Medical Systems, Inc.

Enrollment

1,000 participants

Start Date

May 26, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The registry is to measure longitudinal outcomes and adherence of the Inspire System. The goal of the registry is to capture the life cycle of the patient's use of the Inspire System through routine clinical care visits. There are no required interventions or testing.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry:
  • Capable of giving informed consent, as required per institution
  • Willing to return for routine clinic visits as required for Inspire therapy management

Exclusion Criteria3

  • Any patient who meets any of the following criteria will not be eligible to participate in the registry:
  • Has a life expectancy of less than one year
  • Any reason the clinician deems patient is unfit for participation in the study

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Interventions

DEVICEInspire UAS System

Participants will be implanted with the Inspire UAS System, which is a permanent, implantable therapy that consists of three implantable components: an IPG, a stimulation lead, and a sensing lead. In addition, the study subject receives a remote control to activate the therapy.


Locations(21)

Klinikum Klagenfurt, KABEG

Klagenfurt, Austria

Ordensklinikum Linz

Linz, Austria

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Angers University Hospital Center

Angers, France

CHU Grenoble Alpes

La Tronche, France

Clinique de la Louviere

Lille, France

Hôpital d'Instruction des Armées Laveran

Marseille, France

Clinique Beausoleil

Montpellier, France

CHU Saint Etienne

Saint-Priest-en-Jarez, France

Asklepios Klinik Hamburg

Hamburg, Germany

Universitatsklinikum Hamburg Eppendorf

Hamburg, Germany

Klinik für HNO-Heilkunde/HNO-Schlaflabor

Lübeck, Germany

Otto-von-Guericke-Universität Magdeburg

Magdeburg, Germany

Universitäts-HNO-Klinik Mannheim

Mannheim, Germany

Klinikum Rechts der Isar Technische Universität München

Munich, Germany

Sint Lucas Andreas Ziekenhus (OLVG)

Amsterdam, Netherlands

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, Netherlands

Kantonnspital Baselland-Liestal

Liestal, Switzerland

Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Manchester University NHS Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06971796


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