Clinical trials: sponsored by 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
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
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
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
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
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
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
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
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
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
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
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
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
Alzheimer Disease
ExAblate Blood-Brain Barrier (BBB) Disruption for the 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 disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).
- Trial name
- NCT03671889
- Testing
- Blood Brain Barrier (BBB) Disruption
- Where
- 10 sites in United States
- Volunteers
- 50 people
- Sponsor
- InSightec
Glioblastoma, Glioma
Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for liquid biopsy in subjects with suspected Glioblastoma brain tumors
- Conditions
- Glioblastoma, Glioma, Liquid Biopsy
- Trial name
- NCT05383872
- Testing
- Focused Ultrasound (Exablate Model 4000)
- Where
- 17 sites in United States, Canada
- Volunteers
- 71 people
- Sponsor
- InSightec
Glioma
Safety and Effectiveness of Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma
The purpose of this study is to evaluate the safety and effectiveness of using the Exablate Type 2 system using microbubble resonators (Exablate Test Arm) to disrupt the Blood-Brain Barrier for the purpose of temporarily…
- Trial name
- BBBD (NCT04667715)
- Testing
- Exablate BBBD
- Where
- 2 sites in United States
- Sponsor
- InSightec
Essential Tremor, Parkinson's Disease
Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders:
A global post approval study to collect safety and effectiveness data related to ExAblate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the…
- Conditions
- Essential Tremor, Parkinson's Disease, Movement Disorders, Neuropathic Pain
- Trial name
- NCT03100474
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 500 people
- Sponsor
- InSightec
Essential Tremor
Bilateral Treatment of Medication Refractory Essential Tremor
The purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor.
- Trial name
- NCT04112381
- Testing
- Exablate Model 4000 Type 1.0/1.1
- Where
- 7 sites in United States
- Volunteers
- 51 people
- Sponsor
- InSightec
Movement Disorders, Essential Tremor
ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders
The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients with treatment-refractory symptoms of…
- Conditions
- Movement Disorders, Essential Tremor, Holmes Tremor, Parkinson's Disease
- Trial name
- NCT02252380
- Testing
- Transcranial ExAblate System
- Where
- 2 sites in Canada
- Volunteers
- 10 people
- Sponsor
- InSightec