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Inspire® Upper Airway Stimulation (UAS) System German Post-Market Study

NCT02293746 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-07-02

No results posted yet for this study

Summary

The purpose of this study is to obtain additional safety and efficacy data on the use of Inspire® therapy for the treatment of subjects with moderate to severe Obstructive Sleep Apnea.

Conditions

Interventions

DEVICE

Inspire® Upper Airway Stimulation (UAS) System

This is a single-arm study; all participants will be implanted with the Inspire® Upper Airway Stimulation (UAS) System is a permanent, implantable therapy device, which consists of three implantable components: an IPG, a stimulation lead, and a sensing lead. In addition, the patient receives a remove to activate the therapy.

Sponsors & Collaborators

  • Inspire Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Clemens Heiser, Dr. med. · Klinikum rechts der Isar der Technischen Universität München

  • Joachim T. Maurer, OA Dr. med. · Universitäts-HNO-Klinik Mannheim

  • Armin Steffen, PD Dr. med. · Klinik für HNO-Heilkunde/HNO-Schlaflabor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-12-11
Completion
2017-01-09

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02293746 on ClinicalTrials.gov