Clinical trials: completed, sponsored by InSightec
Parkinson's Disease
ExAblate Transcranial MRgFUS for Unilateral Pallidotomy for the Treatment of Parkinson's Disease
The proposed study is to evaluate the safety and initial effectiveness of the ExAblate Transcranial MRgFUS) treatment of patients with L-dopa induced dyskinesia of Parkinson's disease (LID PD).
- Trial name
- NCT02347254
- Testing
- Transcranial ExAblate
- Where
- Canada
- Volunteers
- 2 people
- Sponsor
- InSightec
Brain Tumor
Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound
The purpose of this study is to evaluate the safety of BBB disruption using transcranial MRI-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent to increase the accumulation of doxorubicin in…
- Trial name
- NCT02343991
- Testing
- Transcranial ExABlate
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- InSightec
Breast Cancer
Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
Non-randomized, Single Arm Clinical study to Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
- Trial name
- NCT02794558
- Testing
- ExAblate MRgFUS
- Where
- Japan
- Volunteers
- 91 people
- Sponsor
- InSightec
Breast Cancer
Study of ExAblate Focused Ultrasound Ablation of Breast Cancer
The goal of this prospective, non-randomized, single-arm, multi site, international study is to develop data to evaluate the safety and effectiveness of the ExAblate MRgFUS system in the ablation of breast cancer and of MRI.
- Trial name
- NCT01620359
- Testing
- ExAblate MRgFUS
- Where
- Germany
- Volunteers
- 14 people
- Sponsor
- InSightec
Tremor, Essential, Neurologic Manifestations
Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Essential Tremor
The objective of this study is to evaluate the safety and feasibility of Auto Focusing (AF) echo imaging using the ExAblate Neuro system
- Conditions
- Tremor, Essential, Neurologic Manifestations, Tremor
- Trial name
- ET004 (NCT03935581)
- Testing
- ExAblate
- Where
- 2 sites in Canada, South Korea
- Volunteers
- 20 people
- Sponsor
- InSightec
Parkinson's Disease
ExAblate Transcranial MRgFUS of the Subthalamic Nucleus for Treatment of Parkinson's Disease
This is primarily a safety protocol to evaluate the safety of subthalamotomy using Transcranial ExAblate for treatment of Parkinson's Disease (PD) motor features.
- Trial name
- NCT02246374
- Testing
- ExAblate Transcranial System
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- InSightec
Parkinson Disease
Safety and Initial Effectiveness of Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease
Safety and Effectiveness in ExAblate Neuro treatment of medication-refractory tremor in subjects with idiopathic Parkinson's disease.
- Trial name
- TDPD (NCT04002596)
- Testing
- ExAblate Neuro Thalamotomy Treatment
- Where
- 2 sites in China, Japan
- Volunteers
- 26 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
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
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
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
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
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