Bion Occipital Nerve Stimulation (ONS) Compassionate Use Study

NCT01050959 | Completed

• 2 other identifiers: A4005G030225/S022
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic, Medically Refractory Headache

Outcome Measures

Primary Outcomes (1)

• Provision of one year of clinical and technical support

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

Interventions

bion DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who were enrolled and implanted with the Bion® system during a prior feasibility clinical investigation of the device for occipital nerve stimulation (ONS) in the United States.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Michigan Head Pain & Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Roshini Jain

  Boston Scientific Neuromodulation Corporation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: January 18, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 13, 2020

Record last verified: 2013-11

Locations

US (2)