The Symani Restore Study

Jacobs institute15 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Moyamoya Disease

Interventions

Symani Surgical SystemDEVICE

To assess the safety and effectiveness of the Symani Surgical System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients aged \>18. 2. Moyamoya disease with minor to moderate symptoms requiring neurosurgical treatment. 3. Patients agree to have the surgery and the anesthesia. 4. 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: 1. Patients who have bleeding or coagulation disorders in the past or present. 2. Any criteria that preclude prolonged anesthesia. 3. Hemodynamically unstable neurological exam. 4. Pressure dependent neurologic status.

Locations (1)

Jacobs Institute

Buffalo, New York, United States

RECRUITING

Outcomes

Primary Outcomes

CT Imaging

Stable cerebral perfusion confirmed with CT Imaging

Time frame: 6 Months

Central Contacts

CARLOS PENA, PhD, MS

CONTACT

17168884814 cpena@jacobsinstitute.org

Data from ClinicalTrials.gov

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