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Stereotactic, Robot-assisted Intracerebral Hemorrhage Clot Evacuation

NCT03414307 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-07-23

No results posted yet for this study

Summary

Non-traumatic intracerebral hemorrhage (ICH) affects approximately 100,000 Americans yearly. Up to 30-50% of ICH is fatal, and those patients who survive are often left with significant neurologic dysfunction. In the past, medical management (e.g., control of hypertension, reversal of antiplatelet or anticoagulants) had been the most effective treatment for these patients, given the morbidity and mortality associated with open surgical treatment for evacuation of ICH. However, recent trials have demonstrated that minimally invasive stereotactic neurosurgical procedures to evacuate ICH are safe and result in improved outcomes for these patients.

Initial attempts to evaluate the efficacy of surgical evacuation of ICH found no significant difference between medical management and standard craniotomy for surgical evacuation. Indeed, open surgery was often discouraged for these patients due to the significant morbidity and mortality associated with the surgical procedure itself. However, research has demonstrated that minimally invasive, image guided stereotactic frame-based and frameless methods are effective and safe for the placement of catheters for clot aspiration and fibrinolytic therapy of ICH in the basal ganglia and other deep seated regions. Larger randomized controlled trials have demonstrated that these minimally invasive approaches also offer clinical benefit for these patients.

Conditions

  • Intracerebral Hematoma

Interventions

PROCEDURE

Intracerebral catheter placement

Image guided stereotactic placement of intra-hemorrhage catheters to evacuate intra-cerebral hemorrhage

DEVICE

Robot-assisted intracerebral catheter

ROSA is a robotic device with trajectory planning software that can be used to aid in planning multiple trajectories to large, irregular clots, and aids in navigating into and out of the cerebral hematoma with minimum human error.

Sponsors & Collaborators

  • University of Pittsburgh Medical Center

    collaborator OTHER

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Oscar Gonzalez, MD, DNP · Zimmer Biomet

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2020-09-30
Completion
2020-09-30
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 NCT03414307 on ClinicalTrials.gov