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Inspire® Upper Airway Stimulation System

NCT02675816 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-08-11

No results posted yet for this study

Summary

The purpose of this post-market study is to assess safety and effectiveness of Inspire Upper Airway System (UAS) in a commercial setting. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe obstructive sleep apnea (OSA) using a randomized controlled trial design.

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. This is a permanent, implantable therapy device, which consists of three implantable components: an implantable pulse generator (IPG), a stimulation lead, and a sensing lead. In addition, the patient receives a handheld remote 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

  • Olivier Vanderveken, Prof. dr. · University Hospital, Antwerp

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Belgium
  • 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 NCT02675816 on ClinicalTrials.gov