The Symani Restore Study
ConditionMoyamoya Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJacobs institute
About this trial
A research study for a neurosurgical procedure in adult patients with Moyamoya disease
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Symani Surgical System
DeviceTo assess the safety and effectiveness of the Symani Surgical System
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Single arm study with neurosurgical procedureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
CT Imaging
Stable cerebral perfusion confirmed with CT Imaging
Time frame
6 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov