NCT07140731

Brief Summary

A research study for a neurosurgical procedure in adult patients with Moyamoya disease

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Sep 2025Sep 2027

First Submitted

Initial submission to the registry

August 21, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

September 20, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

October 16, 2025

Status Verified

October 1, 2025

Enrollment Period

1.9 years

First QC Date

August 21, 2025

Last Update Submit

October 14, 2025

Conditions

Moyamoya Disease

Outcome Measures

Primary Outcomes (1)

  • CT Imaging

    Stable cerebral perfusion confirmed with CT Imaging

    6 Months

Study Arms (1)

Single arm study with neurosurgical procedure

EXPERIMENTAL

To assess the safety and effectiveness of the Symani Surgical System

Device: Symani Surgical System

Interventions

Symani Surgical SystemDEVICE

To assess the safety and effectiveness of the Symani Surgical System

Single arm study with neurosurgical procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacobs Institute

Buffalo, New York, 14203, United States

RECRUITING

MeSH Terms

Conditions

Moyamoya Disease

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

CARLOS PENA, PhD, MS

CONTACT

17168884814cpena@jacobsinstitute.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2025

First Posted

August 26, 2025

Study Start

September 20, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

October 16, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Patient privacy

Locations

US(1)