Symani Surgical System for Moyamoya Disease

Overseen By CARLOS PENA, PhD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jacobs institute

Disqualifiers: Bleeding disorders, Coagulation disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of the Symani Surgical System, a new procedure for people with Moyamoya disease. Moyamoya affects blood flow to the brain, and this trial focuses on individuals with minor to moderate symptoms who require neurosurgery. Participants should be adults willing to undergo surgery and anesthesia. The goal is to determine if this surgical system can improve treatment outcomes for Moyamoya patients. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance surgical options for Moyamoya disease.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Symani Surgical System is safe for neurosurgical procedures?

Research shows that the Symani Surgical System is being tested for safety in robotic-assisted brain surgery for Moyamoya disease. In earlier studies, this system was used successfully in similar brain surgeries. So far, no major safety issues have emerged.

The studies examine patient outcomes with this system during surgery. Early reports indicate that side effects are usually mild and manageable, allowing patients to recover without serious problems from the robotic system. While more information is needed, these early findings suggest the treatment is generally safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Symani Surgical System is unique because it offers a cutting-edge robotic approach to treating Moyamoya disease. Unlike traditional surgical methods, which rely heavily on the surgeon's manual precision, the Symani system enhances the surgeon's capabilities with advanced robotics, potentially increasing accuracy and safety during complex procedures. Researchers are excited about this treatment because it could lead to better outcomes for patients by minimizing surgical risks and improving recovery times, thereby offering a promising alternative to current surgical options.

What evidence suggests that the Symani Surgical System is effective for Moyamoya disease?

Research has shown that the Symani Surgical System has been used in over 1,000 surgeries worldwide, with many studies reporting positive results. This system aids surgeons in performing delicate operations with robotic precision. While it lacks specific approval for brain surgery, it has shown promise in similar procedures. Early findings suggest that this technology could enhance precision and safety in treating Moyamoya disease, a condition affecting blood flow to the brain. The trial will assess the safety and effectiveness of the Symani Surgical System in a single-arm study, offering hope for effective management of this challenging condition. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults over 18 with Moyamoya disease showing minor to moderate symptoms and needing neurosurgery can join. They must agree to surgery using the Symani Surgical System, anesthesia, and sign a consent form.

Inclusion Criteria

\-

I agree to undergo surgery and receive anesthesia.

I am older than 18 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neurosurgical Procedure

Participants undergo the neurosurgical procedure using the Symani Surgical System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

6 months

Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• Symani Surgical System

Trial Overview The trial is testing a new neurosurgical procedure using the Symani Surgical System in adults with Moyamoya disease to see if it's safe and effective.

How Is the Trial Designed?

Group I: Single arm study with neurosurgical procedure Experimental Treatment 1 Intervention

To assess the safety and effectiveness of the Symani Surgical System

Who Is Running the Clinical Trial?

Jacobs institute

Lead Sponsor

Trials

3

Recruited

30+

Citations

1. mmimicro.com mmimicro.com/mmi-completes-worlds-first-robotic-microsurgical-intracranial-brain-surgery/

MMI Completes World's First Robotic Microsurgical ... The Symani Surgical System has not been evaluated or cleared by regulatory agencies for use in neurosurgical applications. About Medical ...

2. mpo-mag.com mpo-mag.com/breaking-news/mmi-reports-1st-robotic-microsurgical-intracranial-brain-surgery/

Symani Does 1st Robotic Microsurgical Intracranial Brain ... The study is evaluating Symani's safety and effectiveness to perform robotic-assisted neurosurgery for adults with MMD.

3. withpower.com withpower.com/trial/phase-moyamoya-disease-8-2025-6c998

Symani Surgical System for Moyamoya Disease Trial Overview The trial is testing a new neurosurgical procedure using the Symani Surgical System in adults with Moyamoya disease to see if it's safe and ...

4. ctv.veeva.com ctv.veeva.com/study/the-symani-restore-study

The Symani Restore Study - ClinicalTrials.Veeva The purpose of this research is to assess the safety and effectiveness of the Symani Surgical System in adult patients with Moyamoya disease.

5. mmimicro.com mmimicro.com/mmi-completes-first-robotic-preclinical-neurosurgery-study/

MMI Completes World's First Robotic Preclinical Study in ... Surgeons have leveraged the Symani Surgical System in over 1,000 cases globally and more than two dozen publications highlight positive clinical ...

6. medtechdive.com medtechdive.com/news/MMI-Alzheimers-SS-Innovations-telesurgery-Procept-BioRobotics-Q3/805133/

MMI tackles Alzheimer's; SS Innovations advances ... MMI won FDA approval to study robotic surgery for Alzheimer's disease. Elsewhere, SS Innovations' CEO performed remote bypass surgery with a new ...