Moyamoya DiseaseNCT07140731
The Symani Restore Study
A study testing Symani Surgical System in people with Moyamoya Disease, run by Jacobs institute at 1 site in United States.
Trial summary
A research study for a neurosurgical procedure in adult patients with Moyamoya disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moyamoya Disease
- What is being tested?
- Symani Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged >18.
- Moyamoya disease with minor to moderate symptoms requiring neurosurgical treatment.
- Patients agree to have the surgery and the anesthesia.
- 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.
- -
Who cannot join
- Patients who have bleeding or coagulation disorders in the past or present.
- Any criteria that preclude prolonged anesthesia.
- Hemodynamically unstable neurological exam.
- Pressure dependent neurologic status.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Jacobs Institute
Buffalo, New York, 14203
About this study
Official title: An Early Feasibility Study for the Symani Surgical System
A research study for a neurosurgical procedure in adult patients with Moyamoya disease
Read the 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.
- Conditions
- Moyamoya Disease
- Being tested
- Symani Surgical System
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symani Surgical SystemDevice
To assess the safety and effectiveness of the Symani Surgical System
| Study group | Role | What they receive |
|---|---|---|
| Single arm study with neurosurgical procedure | Experimental | To assess the safety and effectiveness of the Symani Surgical System Receives: Device: Symani Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT Imaging
Stable cerebral perfusion confirmed with CT Imaging
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start20 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacobs institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Siddiqui, Jacobs institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140731
- Sponsor's protocol ID
- MMI RESTORE CIP-005
- Status last verified
- Oct 2025
- First submitted
- 21 Aug 2025
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Feasibility Study for the Symani Surgical System
- ClinicalTrials.gov ID
- NCT07140731
- Acronym / sponsor ID
- MMI RESTORE CIP-005
- Conditions
- Moyamoya Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Jacobs instituteUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study with neurosurgical procedure | Experimental | Device: Symani Surgical SystemTo assess the safety and effectiveness of the Symani Surgical System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged >18.
- Moyamoya disease with minor to moderate symptoms requiring neurosurgical treatment.
- Patients agree to have the surgery and the anesthesia.
- 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.
- -
Key exclusion criteria (4 listed)
- Patients who have bleeding or coagulation disorders in the past or present.
- Any criteria that preclude prolonged anesthesia.
- Hemodynamically unstable neurological exam.
- Pressure dependent neurologic status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symani Surgical SystemTo assess the safety and effectiveness of the Symani Surgical System | Device | Single arm study with neurosurgical procedure |
Primary outcome
CT Imaging
Time frame: 6 Months
Stable cerebral perfusion confirmed with CT Imaging
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Individual participant dataSharing planned: No. Patient privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symani Surgical System in people with Moyamoya Disease, run by Jacobs institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CARLOS PENA, PhD, MS (17168884814, cpena@jacobsinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT Imaging (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.