Clinical Trials Logo
  1. Home
  2. Intracranial Hemorrhage
  3. NCT02654015

INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo in Patients With Brain Hemorrhage

Intracranial Hemorrhage Clinical Trial

Official title:
INVEST: A Single Arm, Feasibility Study of Minimally Invasive Endoscopic Surgical Treatment With Apollo for Supratentorial Intracerebral Hemorrhage (ICH)

Clinical Trial Summary

The primary objective of this multicenter single arm feasibility study is to provide an assessment of enrollment and follow up feasibility for this patient population being treated with the Apollo Minimally Invasive Surgical Treatment (MIES). Patients who do not qualify for the INVEST Feasibility Study will be referred to the INVEST Registry study.

Clinical Trial Description

Objective: The primary objective of this multicenter single arm feasibility study is to provide an assessment of enrollment and follow up feasibility for this patient population being treated with the Apollo or Artemis Minimally Invasive Surgical Treatment (MIES). Patients who do not qualify for the INVEST Feasibility Study will be referred to the INVEST Registry study. Study Design: This study will be a prospective, multi-centered trial that will enroll 50 patients at up to 10 United States (US) centers. Patient Population: Patients with moderate-large volume (20-80 cc) supratentorial intracerebral hemorrhage (ICH) who present within 24 hours of symptom onset. Enrolled patients will receive minimally invasive endoscopic evacuation with the Apollo system or Artemis Device. Indication: The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems. The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system or cerebrum. In the present study, the researchers propose to investigate the feasibility of studying this patient population for eventual implementation of efficacy trials. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02654015
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact
Status Completed
Phase N/A
Start date June 30, 2017
Completion date September 7, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT00795119 - A Trial to Determine the Efficacy of Near Infrared Spectroscopy to Detect Intracranial Hemorrhage in Children N/A
Completed NCT04062097 - Registration of Idarucizumab for Patients With IntraCranial Hemorrhage
Completed NCT02146040 - Atrial Fibrillation as a Cause of Stroke and Intracranial Hemorrhage Study (The FibStroke Study)
Completed NCT02661672 - INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage N/A
Terminated NCT01463878 - Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study Phase 4
Withdrawn NCT01042574 - The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy Phase 4
Recruiting NCT05517109 - Hemodynamic in Postreperfusion Period and Functional Recovery in Acute Ischemic Stroke Patients N/A
Completed NCT01620203 - Observational Study in Preterm Infants With Intracranial Hemorrhage
Recruiting NCT06096051 - Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage
Completed NCT01850797 - Registry of Acute Stroke Under New Oral Anticoagulants -Pilot (RASUNOA-Pilot) N/A
Completed NCT01115660 - Stroke Education Intervention Trial - Pilot N/A
Completed NCT00413946 - Does Erythropoietin Improve Outcome in Very Preterm Infants? Phase 2
Recruiting NCT00505505 - Intensive Insulin Therapy for Strict Glycemic Control in Neurosurgical Patients: Safety and Efficacy Phase 4
Withdrawn NCT05075486 - Quality Improvement to Reduce Mortality or Severe Intracranial Hemorrhage in Neonatal Extracorporeal Life Support N/A
Recruiting NCT05361070 - Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy
Completed NCT04839770 - MIECH: The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage N/A
Completed NCT02809651 - Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner N/A
Recruiting NCT04819451 - Application of Magnesium-rich Artificial Cerebrospinal Fluid in Subarachnoid Hemorrhage N/A
Terminated NCT00770718 - Factor VII, Prothrombin Complex Concentrate, and Fresh Frozen Plasma in Warfarin-Related Intracranial Hemorrhage Phase 1