Completed NA INTERVENTIONAL 1-arm NCT01532180

Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)

A Pilot Study and Follow Up of the Use of a Hypoglossal Nerve Implant for Treatment of Obstructive Sleep Apnea

Sponsor: ImThera Medical, Inc.

Conditions Respiration Disorders Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Syndrome, Obstructive Sleep Apnea

Interventions aura6000 System

Updated 5 times since 2017 Last updated: Aug 8, 2019 Started: Nov 30, 2009 Primary completion: Dec 31, 2011 Completion: Dec 31, 2011

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01532180, this NA trial focuses on Respiration Disorders and Signs and Symptoms, Respiratory and remains completed. Sponsored by ImThera Medical, Inc., it has been updated 5 times since 2009, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed NA
Jul 2024 — Sep 2024 [monthly]

Completed NA
Jan 2021 — Jul 2024 [monthly]

Completed NA
Sep 2019 — Jan 2021 [monthly]

Completed NA

Phase: PHASE2_PHASE3 → NA
Jan 2017 — Sep 2019 [monthly]

Completed PHASE2_PHASE3

First recorded

Nov 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

ImThera Medical, Inc.

Data source: LivaNova

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Brussels, Belgium