Trials / Completed
CompletedNCT01221948
Vercise Implantable Stimulator for Treating Parkinson's Disease
VANTAGE STUDY Vercise™ Implantable Stimulator for Treating Parkinson's Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).
Detailed description
This is a multi-center, prospective, open label, non-randomized study which will use a within-patient control (each patient serves as his/her own control) to document patient outcomes, including effectiveness, safety, and health economic data for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Deep Brain Stimulation | Rechargeable Deep Brain Stimulation System |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2013-05-01
- Completion
- 2018-06-01
- First posted
- 2010-10-18
- Last updated
- 2025-02-05
- Results posted
- 2015-11-13
Locations
7 sites across 6 countries: Austria, France, Germany, Italy, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01221948. Inclusion in this directory is not an endorsement.