The Symani Restore Study | NCT07140731

Studies
The Symani Restore Study

NCT07140731

Sponsor

Jacobs institute

Status

Recruiting

Last Update Posted

Oct 16, 2025Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Moyamoya Disease

Interventions

Symani Surgical System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2025Actual

Primary Completion Date

Sep 1, 2027Estimated

Completion Date

Sep 1, 2027Estimated

First Submitted Date

Aug 21, 2025

First Submission Date that Met QC Criteria

Aug 22, 2025

First Posted Date

Aug 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2025

Last Update Posted Date

Oct 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm study with neurosurgical procedure	Experimental	To assess the safety and effectiveness of the Symani Surgical System	Device: Symani Surgical System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Symani Surgical System	Device	To assess the safety and effectiveness of the Symani Surgical System	Single arm study with neurosurgical procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CT Imaging	Stable cerebral perfusion confirmed with CT Imaging	6 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

-

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
CARLOS PENA, PhD, MS	Contact	17168884814		cpena@jacobsinstitute.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jacobs Institute	Recruiting	Buffalo	New York	14203	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Patient privacy

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009072	Moyamoya Disease

Ancestor Terms

ID	Term
D002340	Carotid Artery Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided