INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage
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|ClinicalTrials.gov Identifier: NCT02661672|
Recruitment Status : Recruiting
First Posted : January 22, 2016
Last Update Posted : December 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Hemorrhage||Device: Apollo Device Device: Artemis Device||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage: A Prospective Multicenter Registry|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2021|
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.
Device: Apollo Device
The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system.
Other Name: ICH - Apollo System
Device: Artemis Device
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.
- modified Rankin score (mRS) [ Time Frame: 180 days ]Clinical Efficacy Endpoint: global disability assessed via the modified Rankin score (mRS)
- Surgical success rate [ Time Frame: 180 days ]Technical Efficacy Endpoint measured by rate of surgical success
- Rate of Mortality [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661672
|Contact: J Mocco, MD, MSemail@example.com|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: J Mocco, MD, MS firstname.lastname@example.org|
|Contact: Ashley Friend 212-241-2376 email@example.com|
|Principal Investigator: J Mocco, MD, MS|
|Principal Investigator:||J Mocco, MD, MS||Icahn School of Medicine at Mount Sinai|