Clinical trials: sponsored by 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
Glioma, Metastatic Brain Cancer
ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) Treatment of Brain Tumors
A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors
- Trial name
- NCT01473485
- Testing
- ExAblate Transcranial System
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- InSightec
Uterine Fibroid
Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
The goal of this Registry Study is to capture clinical pregnancy outcomes and fibroid treatment background data for any subject post-Exablate treatment for their symptomatic fibroids.
- Trial name
- NCT05386615
- Testing
- Body System - Functional
- Where
- 6 sites in United States, China
- Volunteers
- 200 people
- Sponsor
- InSightec
Parkinson Disease
Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD)
Evaluate the Safety and Effectiveness of Staged Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD).
- Trial name
- NCT04728295
- Testing
- Exablate 4000
- Where
- 9 sites in United States, Spain and 1 more
- Volunteers
- 50 people
- Sponsor
- InSightec
Localized Intermediate Risk Prostate Lesions
Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions
The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential to be an effective non-invasive treatment for intermediate risk, organ-confined prostate lesions, with a low incidence of morbidity.
- Trial name
- NCT01657942
- Testing
- ExAblate MR Guided Focused Ultrasound
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- InSightec
Essential Tremor
ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
The objective of this prospective, randomized, double-blind (to subjects, local site's blinded assessor and Tremor Core Lab assessors), crossover, multi-site, two-arm study (ExAblate treated arm Vs ExAblate Sham treated control…
- Trial name
- NCT01827904
- Testing
- Transcranial ExAblate
- Where
- 8 sites in United States, Canada and 2 more
- Volunteers
- 76 people
- Sponsor
- InSightec
Essential Tremor
Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with…
- Trial name
- NCT02289560
- Testing
- Transcranial ExAblate
- Where
- 7 sites in United States
- Volunteers
- 61 people
- Sponsor
- InSightec
Parkinson Disease
A Clinical Trial for the Safety and Effect of MRGuided FUS Subthalamotomy for Medication Refractory Parkinson's Disease
Study design: This is a prospective, open-label, single-center, and sponsor-initiated clinical trial. The clinical trial follows the Clinical Investigation Plan, GCP.
- Trial name
- NCT04744493
- Testing
- ExaBlate 4000
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- InSightec
Glioblastoma Multiforme
ExAblate Blood-Brain Barrier Disruption for Glioblastoma in Patients Undergoing Standard Chemotherapy
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 Glioblastoma undergoing standard of care therapy.
- Trial name
- NCT03712293
- Testing
- BBB Disruption with Chemotherapy Arm
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- InSightec
Glioblastoma
Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption for Treatment of Glioma
The purpose of this study is to evaluate the safety of blood-brain barrier (BBB) disruption in adult patients with a first presentation of a glioblastoma (GBM) following a maximal safe surgical resection and standard…
- Trial name
- NCT03616860
- Testing
- Focused Ultrasound (FUS) BBB Disruption
- Where
- Canada
- Volunteers
- 14 people
- Sponsor
- InSightec
Trigeminal Neuropathic Pain
Feasibility Study of ExAblate Thalamotomy for Treatment of Chronic Trigeminal Neuropathic Pain
The goal of this prospective, randomized, sham-controlled, crossover study is to evaluate the safety and feasibility of ExAblate Neuro treatment of chronic trigeminal neuropathic pain.
- Trial name
- NCT03309813
- Testing
- Transcranial ExAblate, Crossover Transcranial Exablate
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- InSightec
Prostate Cancer
Focal ExAblate MR-Guided Focused Ultrasound Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer
This study is intended to show that ExAblate™ MRgFUS is a safe procedure that can significantly postpone or eliminate the need of patients with organ confined intermediate risk prostate cancer to undergo a definitive treatment…
- Trial name
- NCT02968784
- Testing
- ExAblate MRgFUS
- Where
- 4 sites in Canada, China and 1 more
- Volunteers
- 53 people
- Sponsor
- InSightec
Essential Tremor
A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Essential Tremor
A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects The objective of this prospective, single-arm study is to test the efficacy…
- Trial name
- NCT03253991
- Testing
- MRgFUS treatment
- Where
- 11 sites in China, Japan and 1 more
- Volunteers
- 154 people
- Sponsor
- InSightec
Bone Metastasis
A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
The study hypotheses is that the proportion of patients experiencing clinically significant pain relief will be at least 30% greater than the proportion experiencing worsening pain.
- Trial name
- NCT01833806
- Testing
- ExAblate MRgFUS
- Where
- 9 sites in United States
- Volunteers
- 32 people
- Sponsor
- InSightec
Epilepsy
MR-Guided Focused Ultrasound in the Treatment of Focal Epilepsy (EP001)
The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of Exablate thermal ablation of a focal epileptic target area in the brain of patients suffering from medication-refractory epilepsy…
- Trial name
- NCT02804230
- Testing
- Neuro Ablation - Functional
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- InSightec
Glioma
ExAblate Blood Brain Barrier Disruption (BBBD) for Planned Surgery in Suspected Infiltrating Glioma
This study is designed to assess the safety and feasibility of using the ExAblate, Type 2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma.
- Trial name
- NCT03322813
- Testing
- ExAblate 4000 - Type 2
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- InSightec
Parkinson's Disease
ExAblate Transcranial MRgFUS of the Globus Pallidum for Treatment of Parkinson's Disease
The proposed study will evaluate the safety, and initial efficacy of using the ExAblate Transcranial to create a unilateral lesion in the globus pallidus as an adjunct to PD medications in subjects who are over 30 years of age…
- Trial name
- NCT02263885
- Testing
- ExAblate Transcranial System
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- InSightec
Parkinson's Disease
ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease
This is a feasibility study to evaluate the safety and initial effectiveness of unilateral ExAblate thermal ablation of the Vim thalamic nucleus of subjects suffering from medication-refractory, idiopathic, tremor-dominant PD…
- Trial name
- NCT01772693
- Testing
- ExAblate Transcranial MRgFUS
- Where
- 2 sites in United States
- Volunteers
- 27 people
- Sponsor
- InSightec
Medication-refractory Obsessive Compulsive Disorder (OCD)
ExAblate Treatment of Medication Refractory Obsessive Compulsive Disorder
The goal of this prospective, non-randomized, single-arm, single site, feasibility study is to develop and collect data to evaluate the safety and initial effectiveness of this treatment using this ExAblate transcranial System in…
- Trial name
- NCT01986296
- Testing
- ExAblate Transcranial MRgFUS System
- Where
- South Korea
- Volunteers
- 25 people
- Sponsor
- InSightec
Bone Metastases
ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain
A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors.
- Trial name
- NCT00981578
- Testing
- ExAblate 2100
- Where
- 5 sites in United States
- Volunteers
- 37 people
- Sponsor
- InSightec