The Symani Restore Study
Purpose
A research study for a neurosurgical procedure in adult patients with Moyamoya disease
Condition
- Moyamoya Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patients aged >18. 2. Moyamoya disease with minor to moderate symptoms requiring neurosurgical treatment. 3. Patients agree to have the surgery and the anesthesia. 4. Patients who voluntarily decide to participate in this study with the surgery performed with the aid of Symani and agree to sign the Informed Consent Form. -
Exclusion Criteria
- Patients who have bleeding or coagulation disorders in the past or present. 2. Any criteria that preclude prolonged anesthesia. 3. Hemodynamically unstable neurological exam. 4. Pressure dependent neurologic status.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Device Feasibility
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Single arm study with neurosurgical procedure |
To assess the safety and effectiveness of the Symani Surgical System |
|
Recruiting Locations
Jacobs Institute
Buffalo, New York 14203
Buffalo, New York 14203
More Details
- NCT ID
- NCT07140731
- Status
- Recruiting
- Sponsor
- Jacobs institute
Detailed Description
The purpose of this research is to assess the safety and effectiveness of the Symani Surgical System in adult patients with Moyamoya disease.