MIS Hematoma Evacuation

NCT04466553 | Withdrawn FDA Device

• 1 other identifier: 20203097
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to determine the effectiveness of the NICO BrainPath™ hematoma evacuation system for patients between the ages of 18 and 80 years old with an intracerebral hematoma. Effectiveness will be defined as the ability to achieve either 70% reduction of intracranial hematoma or to achieve \<15 ml residual hematoma volume following surgery. Additionally, the study aims to compare the mortality and complication rate of patients who undergo minimally invasive, navigation guided endoport based evacuation of intracerebral hematoma with NICO BrainPath™ System as compared to non-operative, supportive standard of care. The study is a prospective, non-randomized cohort study. 50 patients will be enrolled in Group A (NICO BrainPath™ system) and 50 patients will be matched retrospectively of similar diagnosis, undergoing standard of care from Epic). 50 patients will undergo minimally invasive, navigation guided endport based evacuation of intracerebral hematoma with NICO BrainPath™ System. The patient population receiving non-operative supportive care will be matched to the surgical patients based on age, gender, and location of hemorrhage.

Conditions

Intracranial Hematoma

Outcome Measures

Primary Outcomes (1)

• Effectiveness of the NICO BrainPath™ hematoma evacuation system

  The primary objective of this study is to determine the effectiveness of the NICO BrainPath™ hematoma evacuation system for patients between the ages of 18 and 80 years old with an intracerebral hematoma. Effectiveness will be defined as the ability to achieve either 70% reduction of intracranial hematoma or to achieve \<15 ml residual hematoma volume immediately after the surgery.

  immediately after the surgery.

Secondary Outcomes (1)

• Comparison of mortality and complication rate.

  6 months post-op

Study Arms (2)

NICO BrainPath™ Patients

50 patients will be enrolled in Group A NICO BrainPath™ system. The NICO BrainPath™ System has been proposed to reduce high morbidity and mortality associated with ICH through minimally invasive clot evacuation. Previous, single-center trials concluded evacuation of ICH using the BrainPath™ system as being safe and effective. Additionally, previous studies concluded that lesser ICH removal was correlated with mortality benefit and that the NICO BrainPath™ system approach was shown to be safe and effective with a high rate of clot evacuation and functional independence. This system warrants further research because of the need to optimize clinical outcome in these patients and to better define the role of hematoma evacuation in the care of these patients.

Device: NICO BrainPath™ System

Standard of Care

50 patients will be matched retrospectively of similar diagnosis, undergoing standard of care (e.g. no surgical intervention). These patients will be matched to the surgical patients based on age, gender, and location of hemorrhage.

Interventions

NICO BrainPath™ System DEVICE

Patients who are admitted under the neurology service in the Neurocritical Care and Medical ICU will be screened for participation in the trial by their treating physician. Once blood pressure has been stabilized and the best medical treatment has been determined, the patient will need to undergo a standard of care, repeat CT scan 6 hours after stabilization to show that there has been no increase in size of the ICH. Patients that meet eligibility criteria after this CT will be taken to the OR within 24-72 hours for a minimally invasive, navigation guided endoport based evacuation of the clot using the NICO BrainPath™ system.

NICO BrainPath™ Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and females between the ages of 18-80 years old.

You may qualify if:

• and 80 years of age, inclusive
• Spontaneous supratentorial, intracerebral hematoma ICH \>30 ml measured by the ABC/2 method.
• Location of Hemorrhage: Lobar, Putaminal and/or Caudate
• A Glasgow Coma Scale (GCS) of 4 or greater
• Historical Modified Rankin Score (mRS) of 0 (no symptoms of neurological disability) or 1 (no significant disability despite symptoms, able to carry out usual duties and activities).

You may not qualify if:

• Pupils dilated and fixed
• Rapidly deteriorating patient (at the discretion of the surgeon)
• Primary Thalamic Bleed
• Intraventricular Blood (more than 50 % of either ventricle, visual estimate)
• ICH secondary to aneurysm
• Arteriovenous malformation (AVM)
• Tumor
• Moya-Moya
• Sinus thrombosis
• Platelet count \<100,000, INR \>1.4
• Known coagulopathy, on anticoagulants that cannot be reversed

Sponsors & Collaborators

• Lahey Clinic: lead

Study Officials

• Haran Ramachandran, MD

  Lahey Clinic

  PRINCIPAL INVESTIGATOR

• Zoher Ghogawala, MD

  Lahey Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 10, 2020
• Study Start: October 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: December 16, 2021

Record last verified: 2021-12