Bion Occipital Nerve Stimulation (ONS) Compassionate Use Study

The purpose of this compassionate use study is to provide clinical and technical support of the Bion® microstimulator system to the subjects who have decided to keep the system for relief of headache symptoms that have not responded to medical treatment. These study subjects were enrolled and implanted with the Bion® system during a previous clinical investigation of the Bion® for occipital nerve stimulation (ONS) in the United States.

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Key information

Conditions

Chronic, Medically Refractory Headache Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Arizona, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject participated in a prior clinical feasibility study of the Bion for occipital nerve stimulation in the treatment of chronic headaches (IDE G030225) and remained implanted with the Bion system.
Subject elects to enroll in this compassionate use study and provides written informed consent.
Subject understands the type and duration of clinical, technical or product support provided in the study.
Subject is willing to comply with protocol-required activities.

Exclusion criteria

Subject is currently participating or intends to participate in another investigational drug or device clinical trial for chronic headaches during the study period.

Treatment and study plan

BION

Device

Primary outcomes

Provision of one year of clinical and technical support

This is a compassionate use study. There are no primary outcome measures.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Compassionate Use Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jan 18, 2010
Registry last updated: Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed