NCT02654015

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: J. Mocco · Academic / Other
• Sex: All
• Age: 22 Years – 84 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Intracranial Hemorrhage

Interventions

Type	Name	Description
DEVICE	Apollo MIES	Subjects will receive best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System.
OTHER	Medical Management	Subjects will receive best medical management for intracranial hemorrhage

Timeline

• Start date: 2017-06-30
• Primary completion: 2022-09-07
• Completion: 2022-09-07
• First posted: 2016-01-13
• Last updated: 2023-11-22
• Results posted: 2023-11-22

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study