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Minimal Invasive Surgical Intracerebral Hemorrhage Removal

NCT05138341 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-11-03

No results posted yet for this study

Summary

This is a feasibility study trial to determine whether hyperacute (≤8 hour) mechanical Minimal Invasive Surgical (MIS) management is feasible and secondarily improves outcome in patients with spontaneous supratentorial intracranial hemorrhage (ICH).

Patients meeting the inclusion and exclusion criteria, will be enrolled and randomized to either minimally invasive hematoma evacuation (MIS) or best medical management alone (MM). Subjects will be randomly assigned by a central web-based system in a 3:1 manner to treatment with MIS or MM. Data for each subject will be collected at the time of enrollment and treatment, and at subsequent follow-up visits.

Conditions

  • Intracranial Hemorrhages

Interventions

DEVICE

Minimally invasive surgical (MIS) intracranial hemorrhage Evacuation

Patients randomized to MIS group will be undergoing an intervention will get Minimal Invasive Surgical treatment. The market approved Artemis Device (MIS group) will be used. The Artemis Device, Aspiration Pump, and endoscope are used to rinse (irrigate) this area and to gently suction out the rinsing fluid and any blood or clot in brain. The Device is also designed to prevent clogging during the suction of fluid and blood.

Sponsors & Collaborators

  • The Ottawa Hospital

    lead OTHER

Principal Investigators

  • Richard Aviv, MD · Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-12-31
Completion
2025-12-31

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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 NCT05138341 on ClinicalTrials.gov