The Symani Restore Study

Jacobs institute

Status: Enrolling

Conditions: Moyamoya Disease

Treatments: Device: Symani Surgical System

Study type: Interventional

Funder types: Other

Identifiers

NCT07140731

MMI RESTORE CIP-005

Details and patient eligibility

About

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

Full description

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Single arm study with neurosurgical procedure

Experimental group

Description:

To assess the safety and effectiveness of the Symani Surgical System

Treatment:

Device: Symani Surgical System