Clinical trials: sponsored by InSightec
Idiopathic Generalized Epilepsy
High-Intensity Focused Ultrasonic Ablation of the Centromedian Thalamic Nucleus for Treatment of Medically Refractory Generalized Epilepsy in Patients Ages 18 Years to 89 Years
The purpose of this study is to find out if magnetic resonance (MRI)-guided high-intensity focused ultrasound (HIFU) is safe and effective for treating medically refractory generalized epilepsy.
- Trial name
- HIFU for MRGE (NCT07803692)
- Testing
- Intervention 1, Intervention 2
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Oregon Health and Science University
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
Parkinson Disease
Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease.
This study is a randomized clinical trial evaluating a focused ultrasound treatment for people with advanced Parkinson's disease (PD) who have disabling motor complications and symptoms.
- Trial name
- FREEDOM (NCT07764874)
- Testing
- Unilateral Exablate MRgFUS Pallidothalamic Tractotomy, Staged Bilateral Exablate Pallidothalamic Tractotomy, Best Medical Treatment (BMT)
- Where
- South Korea
- Volunteers
- 120 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
Focused Ultrasound, MR-guided FUS
Focused Ultrasound for Drug-resistant Epilepsy
Focused ultrasound (FUS) has been shown to differentially lesion or modulate (excite and inhibit) brain circuit and neural activity across a broad range of acoustic stimulus parameters (intensity, duty cycle, pulse repetition…
- Conditions
- Focused Ultrasound, MR-guided FUS, Drug Refractory Epilepsy, Drug Resistant Epilepsy
- Trial name
- NCT06292494
- Testing
- Exablate 4000 Transcranial MRgfUS System
- Where
- Taiwan
- Volunteers
- 10 people
- Sponsor
- Taipei Veterans General Hospital, Taiwan
Brain Tumor, Non Small Cell Lung Cancer
Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier opening with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned FDA…
- Trial name
- LIMITLESS (NCT05317858)
- Testing
- Blood Brain Barrier Opening - Oncology, Pembrolizumab, Atezolizumab
- Where
- 16 sites in United States, Canada and 1 more
- Volunteers
- 96 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
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
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
Essential Tremor
EMBRACE Tremor BiFUS
This is a post-market (Phase IV) randomized, controlled, blinded, multicenter study with the aim to determine the added value of staged bilateral Exablate thalamotomy compared to a group of patients on previous unilateral…
- Trial name
- NCT06974916
- Testing
- Staged bilateral Exablate thalamotomy, Local standard medical treatment after previous Exablate unilateral thalamotomy.
- Where
- 13 sites in Finland, Germany and 5 more
- Volunteers
- 100 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
Trigeminal Neuralgia
MR Guided Focused Ultrasound (FUS) for the Treatment of Trigeminal Neuralgia
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia.
- Trial name
- NCT04579692
- Testing
- ExAblate Transcranial treatment
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Maryland, Baltimore
Benign Centrally-Located Intracranial Tumors
A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects
The goal of this prospective, non-randomized, single-arm, feasibility study is to develop data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign intracranial tumors which require clinical intervention in…
- Trial name
- NCT03028246
- Testing
- ExAblate 4000 System
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- InSightec
Opioid-use Disorder, Substance Use Disorders
Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)
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) and/or other…
- Trial name
- NCT04197921
- Testing
- Exablate Model 4000 Type 2.0/2.1
- Where
- 4 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- 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
Undifferentiated Pleomorphic Sarcoma
Focused Ultrasound to Promote Immune Responses for Undifferentiated Pleomorphic Sarcoma
This study is a single site, single-arm, feasibility study to evaluate the safety and efficacy of MRgFUS using the ExAblate 2100 System for the partial ablation of undifferentiated pleomorphic sarcomas.
- Trial name
- HIFU-UPS (NCT04123535)
- Testing
- ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Matthew Bucknor
High Grade Glioma
Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma
A Phase 0 single center, first in human, open-label study of ascending energy doses of sonodynamic therapy (SDT) utilizing the MRgFUS combined with intravenous ALA to assess safety and efficacy in up to 45 participants with…
- Trial name
- NCT04559685
- Testing
- SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS), MR-Guided Focused Ultrasound device (MRgFUS)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Nader Sanai
Parkinson Disease
A Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound Subthalamotomy in Patients With Early-Stage Parkinson's Disease
This prospective, randomized, multicenter study aims to evaluate in Early-Stage Parkinson's Disease (ESPD) patients the safety and effectiveness of treatment with Exablate MRgFUS subthalamotomy vs best medical treatment.
- Trial name
- NCT06584383
- Testing
- Exablate MRgFUS subthalamotomy, Best Medical Treatment
- Where
- 4 sites in Chile, Germany and 1 more
- Volunteers
- 67 people
- Sponsor
- InSightec
Essential Tremor, Neurology
Echo-Focusing in Patients With Treatment-Resistant Neurologic and Psychiatric Indications (EF001)
Evaluate the safety and effectiveness of Echo-Focusing using Exablate Neuro as a tool for treating patients with treatment-refractory neurologic and psychiatric disorders.
- Trial name
- NCT05089786
- Testing
- Exablate Neuro Type 1.0 System with Echo Focusing
- Sponsor
- InSightec
Brain Tumor
Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG
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 in combination with Doxorubicin therapy for the treatment of DIPG in pediatric…
- Trial name
- NCT05615623
- Testing
- Exablate, Doxorubicin
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- InSightec