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The goal of collecting proof-of-concept information was met through additional modeling studies, new published evidence and information collected from the study
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The purpose of this study is to provide proof-of-concept that the test product can perform as intended in an intra-operative setting and the responses to the test product are perceivable in a person. The study will also compare results of the test product to the commercially-available product.
Hypothesis: the test product will elicit successful test results in over 90% of test product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study device arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study device HFR0001 | Device | Study device will be tested for up to 2 hours prior to chronic device implant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The HFR0001 device can elicit distinct intra-operative responses in subject symptoms. | Responses include testing parameters and symptom effects | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events that occur with the acute implantation and intra-operative testing of the study device. | Characterization of all adverse events for all subjects from the beginning of the implant procedure through study discontinuation. | 9 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. Maximilian Mehdorn, MD, PhD | University Clinics Kiel, Department of Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christian Albrechts University of Kiel | Kiel | D-24105 | Germany |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |