Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT01050959
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01050959
Study Brief:
Protocol Section:
NCT01050959