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

Status: Completed
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• Patient age 022 years or older

• Supratentorial brain hemorrhage, which may be:

‣ Intracerebral (ICH)

⁃ Primarily Intracerebral (ICH) with a component of intraventricular hemorrhage (IVH)

⁃ Primarily intraventricular hemorrhage (IVH) with a component of ICH

⁃ Intraventricular hemorrhage (IVH)

• Patient does not qualify for the concurrent INVEST Feasibility study

Locations
United States
Washington, D.c.
George Washington University
Washington
Kentucky
University of Louisville
Louisville
New York
University of Buffalo
Buffalo
Icahn School of Medicine at Mount Sinai
New York
Pennsylvania
Geisinger Medical Center
Danville
South Carolina
Prisma Health
Greenville
Washington
University of Washington
Seattle
Time Frame
Start Date: 2016-10-14
Completion Date: 2022-11-16
Participants
Target number of participants: 38
Treatments
Experimental: Patients with Brain Hemorrhage
Subjects will receive best medical management for ICH plus they will receive the MIES surgery and use of the Apollo or Artemis System for clot evacuation.
Sponsors
Leads: J. Mocco
Collaborators: University at Buffalo, MOUNT SINAI HOSPITAL

This content was sourced from clinicaltrials.gov