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The primary aim of minimally invasive surgery (MIS) for supratentorial intracranial hemorrhage is to achieve an atraumatic evacuation of blood products from the brain to prevent the secondary injury that occurs after the initial bleed. The purpose of this Phase II randomized trial is to provide an initial assessment of the efficacy of MIES to improve outcomes in patients with supratentorial ICH. Subjects will be randomized to either medical management or medical management with MIS.
Objective: The primary objective of this multicenter randomized controlled trial is to provide an initial assessment of the safety and efficacy of minimally invasive endoscopic surgery with Apollo for the evacuation of intracerebral hemorrhage (ICH)
Study Design: This study will be a prospective, randomized, multi-centered international trial that will enroll up to 180 patients at up to 30 US centers and 5 centers outside of the United States. Patients will be followed for 12 months.
Patient Population: Patients with moderate-large volume (20-80 cc) supratentorial intracerebral hemorrhage (ICH) who present within 24 hours of symptom onset. Patients will be randomized to either minimally invasive endoscopic evacuation with the Apollo system or best medical management (2:1).
Indication: The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system. In the present study, the investigators propose to investigate the safety and efficacy of this system for the minimally invasive evacuation of intracerebral hemorrhage.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Apollo MIES, Medical Management
Icahn School of Medicine at Mount Sinai
Not yet recruiting
Icahn School of Medicine at Mount Sinai
Published on BioPortfolio: 2016-01-14T12:53:24-0500
Objective: The primary objective of this multicenter prospective registry is to provide additional safety, technical outcomes and clinical outcomes data for minimally invasive endoscopic s...
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Bleeding into the intracranial or spinal SUBARACHNOID SPACE, most resulting from INTRACRANIAL ANEURYSM rupture. It can occur after traumatic injuries (SUBARACHNOID HEMORRHAGE, TRAUMATIC). Clinical features include HEADACHE; NAUSEA; VOMITING, nuchal rigidity, variable neurological deficits and reduced mental status.
Business management of medical and dental practices that may include capital financing, utilization management, and arrangement of capitation agreements with other parties.
Abnormal outpouching in the wall of intracranial blood vessels. Most common are the saccular (berry) aneurysms located at branch points in CIRCLE OF WILLIS at the base of the brain. Vessel rupture results in SUBARACHNOID HEMORRHAGE or INTRACRANIAL HEMORRHAGES. Giant aneurysms (>2.5 cm in diameter) may compress adjacent structures, including the OCULOMOTOR NERVE. (From Adams et al., Principles of Neurology, 6th ed, p841)
A well-circumscribed mass composed of tuberculous granulation tissue that may occur in the cerebral hemispheres, cerebellum, brain stem, or perimeningeal spaces. Multiple lesions are quite common. Management of intracranial manifestations vary with lesion site. Intracranial tuberculomas may be associated with SEIZURES, focal neurologic deficits, and INTRACRANIAL HYPERTENSION. Spinal cord tuberculomas may be associated with localized or radicular pain, weakness, sensory loss, and incontinence. Tuberculomas may arise as OPPORTUNISTIC INFECTIONS, but also occur in immunocompetent individuals.
Bleeding into the SUBARACHNOID SPACE due to CRANIOCEREBRAL TRAUMA. Minor hemorrhages may be asymptomatic; moderate to severe hemorrhages may be associated with INTRACRANIAL HYPERTENSION and VASOSPASM, INTRACRANIAL.
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