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PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase

NCT04178746 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2022-09-14

No results posted yet for this study

Summary

The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in subjects with intraventricular hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase.

Conditions

  • Intracerebral Hemorrhage
  • Brain Hemorrhage
  • Intraventricular Hemorrhage

Interventions

DEVICE

Artemis Neuro Evacuation 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. The Artemis Device will be evaluated by descriptive statistics in this registry to assess its efficiency and reliability in minimally invasive, mechanical evacuation of hematoma in patients with intracranial hemorrhage under direct visualization and control using a neuroendoscope.

Sponsors & Collaborators

  • Penumbra Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Saphier, MD · Atlantic Neuroscience Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2021-06-02
Completion
2021-06-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04178746 on ClinicalTrials.gov