Clinical trials: open to volunteers, sponsored by 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, 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
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
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
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
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
Parkinsons Disease
MR-guided Focused Ultrasound Plus GCase
The goal of this study is to establish safety and feasibility of intracerebral delivery of GCase via MRgFUS. This technique may offer potential benefits given the exposure of the putamen to GCase in animal models has been shown…
- Trial name
- NCT05565443
- Testing
- Blood Brain Barrier Disruption - Functional
- Where
- Canada
- Volunteers
- 14 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
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