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Stereotactic, Robot-assisted Intracerebral Hemorrhage Clot Evacuation

NCT03414307 · Zimmer Biomet · Updated 23 July 2021

What is being tested
Intracerebral catheter placement; Robot-assisted intracerebral catheter
For
Intracerebral Hematoma
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 85 years. The full rules are on the registry page.
Where
United States
When
Starts or started 30 Sept 2020, ends 30 Sept 2020. Registered 29 Jan 2018.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT03414307

Sites

  • UPMC Stroke InstitutePittsburgh, Pennsylvania, United States