Symani Restore surgery for Moyamoya disease
An Early Feasibility Study for the Symani Surgical System
This study tests using the Symani Surgical System to assist surgeons performing neurosurgery in adults with moyamoya disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jacobs institute Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT07140731 on ClinicalTrials.gov |
What this trial studies
This is a prospective, interventional study of the Symani Surgical System in adults with moyamoya disease who require neurosurgical treatment. Eligible patients (>18 years) will undergo the planned surgical procedure with the aid of the Symani device and will be followed for safety and device-related outcomes. The trial enrolls patients at the Jacobs Institute in Buffalo, New York, and applies standard inclusion and exclusion criteria for operative candidates. Investigators will record perioperative safety, technical performance, and clinical recovery measures to determine device effectiveness in this population.
Who should consider this trial
Good fit: Adults over 18 with moyamoya disease who have minor to moderate symptoms and are candidates for neurosurgical treatment and general anesthesia are ideal candidates.
Not a fit: Patients with current or past bleeding/coagulation disorders, those who cannot tolerate prolonged anesthesia, hemodynamically unstable neurological exams, or pressure-dependent neurologic status are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, using the Symani system could improve the precision of delicate cerebrovascular procedures and potentially reduce surgical complications.
How similar studies have performed: Robotic-assisted microsurgery has shown promise in other microvascular procedures, but application specifically for moyamoya disease is limited and this study is among the early tests of Symani in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Buffalo, New York
- Jacobs Institute — Buffalo, New York, United States (Recruiting)
Study contacts
- Study coordinator: CARLOS PENA, PhD, MS
- Email: cpena@jacobsinstitute.org
- Phone: 17168884814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.