Clinical trials: Hematoma Intracranial
Intracerebral Hematoma
Stereotactic, Robot-assisted Intracerebral Hemorrhage Clot Evacuation
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.
- Trial name
- NCT03414307
- Testing
- Intracerebral catheter placement, Robot-assisted intracerebral catheter
- Where
- United States
- Sponsor
- Zimmer Biomet
Subdural Hematoma
MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma
The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the NeoCast Embolic System for treatment of symptomatic subacute or chronic subdural hematoma (SDH)…
- Trial name
- RADIANT (NCT07541404)
- Testing
- NeoCast Embolic System, Onyx LES, an FDA-Approved Commercial Liquid Embolic
- Where
- 2 sites in United States
- Volunteers
- 360 people
- Sponsor
- Arsenal Medical, Inc.
Chronic Subdural Hematoma, cSDH
Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy
All participants will be asked to have a minimally invasive procedure for the treatment of chronic subdural hematoma, a blood clot on the brain.
- Conditions
- Chronic Subdural Hematoma, cSDH, Chronic Subdural Hematomas
- Trial name
- iCURE cSDH (NCT07214623)
- Testing
- Neuro endovascular embolic coil
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- Kaneka Medical America LLC
Subdural Hematoma
Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma
The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma…
- Trial name
- EMBOLISE (NCT04402632)
- Testing
- Surgical Management, Onyx™ Liquid Embolic System (LES) Embolization, Observation Only
- Where
- 49 sites in United States
- Volunteers
- 600 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Chronic Subdural Hematomas
PHIL™ Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma IDE Trial
This is a prospective, randomized, controlled, open-label, blinded endpoint (PROBE) clinical investigation in which patients with non-emergent chronic subdural hematoma (cSDH) requiring treatment will be randomized (1:1) to…
- Trial name
- PHILFIRST (NCT07576998)
- Testing
- PHIL™ (Precipitating Hydrophobic Injectable Liquid), Surgical evacuation
- Volunteers
- 475 people
- Sponsor
- Microvention-Terumo, Inc.
Ischemic Stroke, Intracranial Hematoma
Investigation of Clot in Ischemic Stroke and Hematoma Evacuation
The aim of the study is to collect and analyze specimen from ischemic stroke patients undergoing thrombectomy procedures and from patients undergoing minimally invasive surgery for intracranial hematoma evacuation.
- Trial name
- INSIGHT (NCT04693767)
- Testing
- Mechanical thrombectomy, Minimally invasive surgery
- Where
- 27 sites in United States
- Volunteers
- 400 people
- Sponsor
- Penumbra Inc.
Intracerebral Hemorrhage, Cerebral Hemorrhage
ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)
This is a multicenter, randomized, adaptive clinical trial comparing standard medical management to early (<24 hours) surgical hematoma evacuation using minimally invasive parafascicular surgery (MIPS) in the treatment of acute…
- Conditions
- Intracerebral Hemorrhage, Cerebral Hemorrhage, Intracerebral Haemorrhage
- Trial name
- ENRICH (NCT02880878)
- Testing
- Early Surgical Hematoma Evacuation
- Where
- 36 sites in United States
- Volunteers
- 300 people
- Sponsor
- Nico Corporation
Cerebral Hemorrhage, Intraventricular Hemorrhage
Active Removal of IntraCerebral Hematoma Via Active Irrigation
Study evaluating if active irrigation by IRRAflow® with infusion of tPA will reduce the time needed for clearance of intracerebral and intraventricular hemorrhage compared with passive drainage.
- Trial name
- ARCH (NCT05118997)
- Testing
- IRRAflow, EVD
- Where
- Finland
- Volunteers
- 60 people
- Sponsor
- IRRAS
Acquired Bleeding Disorder, Intracerebral Haemorrhage
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) for preventing early hematoma growth…
- Trial name
- NCT01563445
- Testing
- activated recombinant human factor VII
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Novo Nordisk A/S
Intracerebral Hemorrhage, Cerebral Hemorrhage
MIECH: The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage
The primary objective of this trial is to provide preliminary safety data of minimally invasive endoscopic surgery using the Axonpen™ system for spontaneous intracerebral hemorrhage (ICH).
- Conditions
- Intracerebral Hemorrhage, Cerebral Hemorrhage, Intracranial Hemorrhage, Basal Ganglia Hemorrhage
- Trial name
- NCT04839770
- Testing
- Axonpen system
- Where
- Taiwan
- Volunteers
- 10 people
- Sponsor
- Clearmind Biomedical Inc.
Traumatic Subdural Hematoma
Factors Influencing Readmission Rates of Acute Traumatic Subdural Hematoma in the Elderly
Acute traumatic subdural hematomas (TSDH) readmission rate is high (27.8%) with an increase in morbidity and cost for the elderly.
- Trial name
- NCT03878043
- Testing
- Follow-up Care
- Where
- United States
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- Tarik Wasfie, MD
Subdural Hematoma, Subdural Hematoma, Chronic
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH)
The aim of the study is to proof the effectiveness of Histoacryl® on preventing recurrence or progression of subdural hematoma after embolization of the middle meningeal artery.
- Trial name
- HARMONY (NCT07258069)
- Testing
- Histoacryl®
- Where
- 6 sites in Japan
- Volunteers
- 178 people
- Sponsor
- Aesculap AG
Traumatic Brain Hemorrhage
SAFETY: Stabilization Points to Third Hospital Line Assessment oF the Impact of the usE of Infrascanner Model 2500 to Provide Decision Support for Diagnosis/Screening of Traumatic Brain InjurY in Ukraine
The Infrascanner model 2500 is a handheld, noninvasive device that is FDA-cleared to detect traumatic intracranial hematomas. FDA clearance K200203 was issued in 2020, K211617 added pediatric age group to the IFU in 2022, and…
- Trial name
- SAFETY (NCT07014748)
- Testing
- Handheld brain hematoma detector
- Where
- 4 sites in United States, Ukraine
- Volunteers
- 600 people
- Sponsor
- InfraScan, Inc.
Intracerebral Hemorrhage
Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage
This study employs a modified continual reassessment method (mCRM) design to estimate the maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based on treatment emergent thromboembolic and/or…
- Trial name
- NCT02687191
- Testing
- PF-05230907
- Where
- 13 sites in United States, Canada and 2 more
- Volunteers
- 21 people
- Sponsor
- Pfizer
Subdural Hematoma, Chronic
The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)
STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1) controlled trial designed to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for…
- Trial name
- STEM (NCT04410146)
- Testing
- SQUID Embolization, SQUID Embolization and Surgical Evacuation, Surgical Evacuation
- Where
- 32 sites in United States, France and 2 more
- Volunteers
- 319 people
- Sponsor
- Balt USA
Chronic Subdural Hematoma
Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas…
- Trial name
- MEMBRANE (NCT04816591)
- Testing
- Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System, Standard of Care Surgery, Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic System
- Where
- 33 sites in United States, China
- Volunteers
- 376 people
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
Intracerebral Hemorrhage
A PILOT TRIAL of a DISPOSABLE INTRACEREBRAL ASPIRATION ENDOSCOPE for the TREATMENT of INTRACEREBRAL HEMATOMA（FAST-HET）
This clinical trial is a prospective, open-label, single-arm clinical trial. According to the inclusion and exclusion criteria specified in the trial protocol, no fewer than 16 subjects with cerebral hemorrhage will be enrolled…
- Trial name
- NCT06843616
- Testing
- Endoscopic surgery
- Where
- China
- Volunteers
- 16 people
- Sponsor
- MicroPort NeuroTech Co., Ltd.