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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02661672
Other study ID # GCO 16-0028
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2016
Est. completion date November 16, 2022

Study information

Verified date March 2023
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


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Study Design


Intervention

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.
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.

Locations

Country Name City State
United States University of Buffalo Buffalo New York
United States Geisinger Medical Center Danville Pennsylvania
United States Prisma Health Greenville South Carolina
United States University of Louisville Louisville Kentucky
United States Icahn School of Medicine at Mount Sinai New York New York
United States University of Washington Seattle Washington
United States George Washington University Washington District of Columbia

Sponsors (3)

Lead Sponsor Collaborator
J. Mocco MOUNT SINAI HOSPITAL, University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary modified Rankin score (mRS) Clinical Efficacy Endpoint: global disability assessed via the modified Rankin score (mRS) 180 days
Primary Surgical success rate Technical Efficacy Endpoint measured by rate of surgical success 180 days
Primary Rate of Mortality 30 days
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