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Recruiting

NCT Number: NCT07140731

The Symani Restore Study

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

Recruiting

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Key information

Conditions

Moyamoya Disease Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jacobs Institute

Buffalo, New York, 14203, United States

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Symani Surgical System

Device

To assess the safety and effectiveness of the Symani Surgical System

Primary outcomes

  1. CT Imaging

    Time frame: 6 Months

    Stable cerebral perfusion confirmed with CT Imaging

Study contacts

Contact information is provided by the study sponsor or research team.

CARLOS PENA, PhD, MS

CONTACT

[email protected]

17168884814

Sponsors and collaborators

Lead sponsor

Jacobs institute

Other

Registry information

Official study title

An Early Feasibility Study for the Symani Surgical System

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2025
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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