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INVEST: Minimally Invasive Endoscopic Surgery vs. Medical Management in Supratentorial Intraparenchymal Hemorrhage

2016-01-14 12:53:24 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Intracranial Hemorrhage

Intervention

Apollo MIES, Medical Management

Location

Icahn School of Medicine at Mount Sinai
New York
New York
United States
10029

Status

Not yet recruiting

Source

Icahn School of Medicine at Mount Sinai

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-01-14T12:53:24-0500

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