Clinical trials: sponsored by 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
Opioid Use Disorder
Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD)
The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the Exablate® Model 4000 Type 2.0/2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) by assessing its…
- Trial name
- NCT06612788
- Testing
- Exablate Model 4000 Type 2.0/2.1
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- West Virginia University
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
Prostate Cancer
Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions
This extended clinical investigation is a multicenter, prospective, single arm study intended to provide continued access of the Exablate Model 2100 device (Exablate Prostate) to patients for treatment of prostate lesions and…
- Trial name
- NCT03998657
- Testing
- Exablate Prostate Treatment
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- InSightec
Brain Tumor
MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors
The purpose of this study is to evaluate the safety of MRI-guided focused ultrasound thermal ablation of brain tumors performed through intact human skull using the ExAblate transcranial system.
- Trial name
- NCT00147056
- Testing
- ExAblate transcranial system
- Where
- 2 sites in United States
- Volunteers
- 10 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
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
Recurrent Glioblastoma
Randomized Study of Neo-adjuvant and Adjuvant Pembrolizumab With and Without Targeted Blood Brain Barrier Opening Using Exablate MRI-guided Focused Ultrasound (Exablate MRgFUS) for Recurrent Glioblastoma
To learn if the Exablate Model 4000 Type 2 ("Exablate System") with the DEFINITY® ultrasound contrast agent can temporarily disrupt the blood brain barrier in patients with recurrent (has grown back) glioblastoma who are…
- Trial name
- NCT05879120
- Testing
- Pembrolizumab, Exablate MRgFUS + neoadjuvant pembolizumab
- Where
- United States
- Sponsor
- M.D. Anderson Cancer Center
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
Uterine Fibroids, Pregnancy
Safety Trial of Magnetic Resonance (MR) Guided Focused Ultrasound Surgery (FUS) in Women With Uterine Fibroids Wishing to Pursue Pregnancy in the Future
The study objective is to develop data for the safety of pregnancies after thermal ablation of uterine fibroids by MR guided Focused Ultrasound using the Ex Ablate 2000 system.
- Trial name
- NCT00180739
- Testing
- Magnetic Resonance Guided Focused Ultrasound
- Where
- United Kingdom
- Volunteers
- healthy volunteers welcome
- Sponsor
- Imperial College London