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Inspire® Post-Approval Study / Protocol Number 2014-001

NCT02413970 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2024-12-27

No results posted yet for this study

Summary

The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.

Conditions

Interventions

DEVICE

Inspire® UAS System

This is a single-arm study; all 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.

Sponsors & Collaborators

  • Inspire Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Gwen Gimmestad · Inspire Medical Systems, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2025-03-31
Completion
2025-06-30

Countries

  • United States

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 NCT02413970 on ClinicalTrials.gov