Clinical trials: sponsored by InSightec
Brain Tumor
Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG)
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type2.0/2.1 in combination with Doxorubicin therapy for the treatment of DIPG in pediatric…
- Trial name
- NCT05630209
- Testing
- Exablate, Doxorubicin
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- InSightec
Glioma, Malignant, Glioblastoma
Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption in GBM Patients
The purpose of this study is to evaluate the safety of the Exablate Model 4000 Type 2.0 used as a tool to disrupt the BBB in patients with high grade glioma undergoing standard of care therapy.
- Trial name
- NCT04998864
- Testing
- Magnetic Resonance guided Focused ultrasound (MRgFUS)
- Where
- 2 sites in Italy, Spain
- Volunteers
- 3 people
- Sponsor
- InSightec
Parkinson Disease
A Study to Evaluate the Safety and Efficacy of ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features
The objective of this study is to test the efficacy and safety of unilateral subthalamotomy performed using the ExAblate System for the treatment of Parkinson's disease (PD) motor features.
- Trial name
- NCT03454425
- Testing
- Exablate Subthalamotomy
- Where
- Spain
- Volunteers
- 36 people
- Sponsor
- InSightec
Essential Tremor
Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
The objective of this prospective, multi-site, single-arm, open-label study is to capture the safety and efficacy (outcome) of bilateral staged Exablate treatment in subjects with bilateral medication-refractory essential tremor…
- Trial name
- NCT03465761
- Testing
- ExAblate
- Where
- 2 sites in Spain, United Kingdom
- Volunteers
- 7 people
- Sponsor
- InSightec
Parkinson Disease
Blood-Brain-Barrier Disruption With Cerezyme in Patient's With Parkinson's Disease
This clinical trial focus on the delivery of Cerezyme® in Parkinson's Disease (PD) patients using MR-guided focused ultrasound (MRgFUS) induced opening of the blood-brain barrier (BBB).
- Trial name
- NCT04370665
- Testing
- Exablate BBBD with Cerezyme
- Where
- Canada
- Volunteers
- 4 people
- Sponsor
- InSightec
Recurrent Glioblastoma
Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy
The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing…
- Trial name
- NCT04417088
- Testing
- Carboplatin, Exablate BBBD
- Where
- 4 sites in United States
- Volunteers
- 28 people
- Sponsor
- InSightec
Neuropathic Pain
Study of MRgFUS Exablate Treatment Following the Neuropathic Pain
The objective of this study is to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment.
- Trial name
- NCT04649554
- Testing
- Exablate treatment
- Where
- Italy
- Volunteers
- 2 people
- Sponsor
- InSightec
Tremor Associated With Tremor Dominant Parkinson's Disease
A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease
The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.
- Trial name
- NCT04991831
- Testing
- Unilateral thalamotomy
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 50 people
- Sponsor
- InSightec
Breast Cancer, Brain Metastases
Blood Brain Barrier Disruption (BBBD) Using MRgFUS in the Treatment of Her2-positive Breast Cancer Brain Metastases
The purpose of this study is to evaluate the safety of BBB disruption using the ExAblate 4000-system Type 2 in patients with Her-2 positive breast cancer metastases in the brain.
- Trial name
- BBBD (NCT03714243)
- Testing
- ExAblate BBBD
- Where
- Canada
- Volunteers
- 8 people
- Sponsor
- InSightec
Parkinson Disease
ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease
Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic…
- Trial name
- NCT03319485
- Testing
- ExAblate Pallidotomy
- Where
- 20 sites in United States, Canada and 6 more
- Volunteers
- 92 people
- Sponsor
- InSightec
Amyotrophic Lateral Sclerosis
Blood-Brain Barrier Opening Using MR-Guided Focused Ultrasound in Patients With Amyotrophic Lateral Sclerosis
The purpose of this study is to evaluate the safety, tolerability, and feasibility of Blood-Brain Barrier (BBB) opening using transcranial MRI-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent…
- Trial name
- NCT03321487
- Testing
- Blood-Brain Barrier opening with MRgFUS
- Where
- Canada
- Volunteers
- 4 people
- Sponsor
- InSightec
Glioma, Glioblastoma
Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption
The purpose of this study is to evaluate the safety of the ExAblate Model 4000 Type 2 used as a tool to disrupt the BBB (blood brain barrier) in patients with high grade glioma undergoing standard of care therapy.
- Trial name
- NCT03551249
- Testing
- Focused ultrasound (FUS)
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- InSightec
Movement Disorders, Neurology
A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications
This registry is a prospective, multicenter, international, single arm, observational post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years.
- Conditions
- Movement Disorders, Neurology, Parkinsons Disease
- Trial name
- NCT05539196
- Testing
- Exablate Pallidotomy, Unilateral
- Where
- 5 sites in United States, Japan
- Volunteers
- 60 people
- Sponsor
- InSightec
Parkinsons Disease With Dementia
A Study to Evaluate Temporary Blood Brain Barrier Disruption in Patients With Parkinson's Disease Dementia
The goal of this prospective, non-randomized, single-arm, feasibility study is to develop data to evaluate the safety and initial efficacy of this treatment (temporary disruption of the BBB) using this ExAblate Model 4000 Type 2…
- Trial name
- NCT03608553
- Testing
- MR Guided Focused Ultrasound
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- InSightec
Parkinson Disease, Neurologic Manifestations
A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD
The objective of this study is to test the safety and preliminary efficacy of staged bilateral subthalamotomy performed using the ExAblate Transcranial System for the treatment of Parkinson's disease (PD) motor features
- Trial name
- NCT03964272
- Testing
- Exablate Bilateral Subthalamotomy
- Where
- Spain
- Volunteers
- 6 people
- Sponsor
- InSightec
Task-Specific Focal Dystonia
MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating task specific focal hand dystonias (TSFD).
- Trial name
- FUS Dystonia (NCT06367608)
- Testing
- ExAblate Transcranial treatment
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Maryland, Baltimore
Parkinsons Disease
MR-guided Focused Ultrasound Plus GCase
The goal of this study is to establish safety and feasibility of intracerebral delivery of GCase via MRgFUS. This technique may offer potential benefits given the exposure of the putamen to GCase in animal models has been shown…
- Trial name
- NCT05565443
- Testing
- Blood Brain Barrier Disruption - Functional
- Where
- Canada
- Volunteers
- 14 people
- Sponsor
- InSightec
Mild Cognitive Impairment, Alzheimer Disease 1
Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment or Mild Alzheimer's Disease Undergoing Standard of Care Monoclonal Antibody (mAb) Therapy
The purpose of this study is to assess the safety and feasibility of administering standard of care monoclonal antibody (mAb) infusion therapy in combination with opening the blood-brain barrier with the Exablate Model 4000 Type…
- Trial name
- NCT05469009
- Testing
- Aducanumab, Exablate Model 4000 Type 2, Lecanemab
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Ali Rezai
Alzheimer Disease
ExAblate Blood-Brain Barrier Opening for Treatment of Alzheimer's Disease
The purpose of this study is to evaluate the safety and efficacy of the ExAblate® Model 4000 Type 2.0 system as a tool to open the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).
- Trial name
- NCT03739905
- Testing
- Blood Brain Barrier (BBB) Disruption
- Where
- Canada
- Volunteers
- 35 people
- Sponsor
- InSightec
Recurrent Glioblastoma
Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM
The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing…
- Trial name
- NCT04440358
- Testing
- Exablate BBBD, Carboplatin
- Where
- 3 sites in Canada, Italy and 1 more
- Volunteers
- 13 people
- Sponsor
- InSightec