Moyamoya Disease
Conditions
Brief summary
A research study for a neurosurgical procedure in adult patients with Moyamoya disease
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.
Interventions
DEVICESymani Surgical System
To assess the safety and effectiveness of the Symani Surgical System
Sponsors
Jacobs institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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
1. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CT Imaging | 6 Months | Stable cerebral perfusion confirmed with CT Imaging |
Countries
United States
Contacts
Primary ContactCARLOS PENA, PhD, MS
Outcome results
None listed