A study to check results in patients having epilepsy when treated with the Vagal Nerve Stimulation (VNS)Therapy System
Phase 4
- Conditions
- Health Condition 1: G409- Epilepsy, unspecified
- Registration Number
- CTRI/2019/07/020439
- Lead Sponsor
- ivaNova USA Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
To be eligible for enrollment, the subject must meet the following criteria:
1 Clinical diagnosis of drug resistant epilepsy treated with VNS Therapy. Eligible subjects include those not previously treated
with VNS Therapy as well as subjects receiving replacement generators.
2 Able and willing to comply with the frequency of study visits.
3 Subject, or legal guardian, voluntarily signs an informed consent in accordance with institutional policies. In the event that the subject is under the age of 18, the subject may also be required to sign an assent affirming their agreement to participate.
Exclusion Criteria
1 There are no exclusion criteria. Investigators should refer to the local
instructions for use for VNS Therapy
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method