Clinical Trials Logo
  1. Home
  2. Intracranial Hemorrhage
  3. NCT02661672

INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage

Intracranial Hemorrhage Clinical Trial

Official title:
INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage: A Prospective Multicenter Registry

Clinical Trial Summary

Objective: The primary objective of this multicenter prospective registry is to provide additional safety, technical outcomes and clinical outcomes data for minimally invasive endoscopic surgery (MIES) with Apollo or Artemis for the evacuation of supratentorial brain hemorrhage in adult patients who do not qualify for the concurrent INVEST Feasibility randomized controlled trial at active INVEST centers.

Clinical Trial Description

Study Design: This study will be a prospective, non-randomized, multi-center, single arm registry that will enroll up to 50 patients, however may increase to 200 at up to 10 US centers. Patient Population: Adult patients with supratentorial brain hemorrhages (ICH and/or IVH) who do not meet all INCLUSION criteria or who meet one or more EXCLUSION criteria for the INVEST trial, but who will ultimately undergo MIES with Apollo or Artemis at active INVEST centers. 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. In the present study, the researchers propose to investigate the safety and efficacy of this system for the minimally invasive evacuation of brain hemorrhage - both IVH, IVH with ICH and ICH alone - in patients who do not qualify for the INVEST trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02661672
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact
Status Completed
Phase N/A
Start date October 14, 2016
Completion date November 16, 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)
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
Completed NCT05517109 - Hemodynamic in Postreperfusion Period and Functional Recovery in Acute Ischemic Stroke Patients N/A
Completed NCT02654015 - INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo in Patients With Brain Hemorrhage 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