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Recruiting NCT07140731

The Symani Restore Study

No phase Interventional Moyamoya Disease

For patients and families

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Symani Surgical System.
Who it may be relevant to
Registry conditions: Moyamoya Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Early Feasibility Study for the Symani Surgical System

Overview

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.

Interventions

  • Device Symani Surgical System
    To assess the safety and effectiveness of the Symani Surgical System

Primary outcome measures

  • CT Imaging [Time frame: 6 Months]

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.

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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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • Jacobs Institute — Buffalo

Identifiers

NCT: NCT07140731 · MMI RESTORE CIP-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗