Clinical trials: sponsored by 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
Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury, Spinal Cord Injuries
MR Guided Focused Ultrasound for Treatment of Neuropathic Pain
Neuropathic pain is often a result of direct diseases of peripheral or central nervous system with an estimated prevalence of 8% of adults and this pain is associated with significant consequences because of longer symptom…
- Conditions
- Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury, Spinal Cord Injuries, Phantom Limb Pain
- Trial name
- NCT03111277
- Testing
- Experimental: ExAblate Transcranial treatment
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Maryland, Baltimore
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
Bone Metastases, Multiple Myeloma
ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain
A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone and Multiple Myeloma Tumors for the Palliation of Pain in Patients Who are not Candidates for Radiation Therapy
- Trial name
- NCT00656305
- Testing
- ExAblate MRfFUS
- Where
- 14 sites in United States, Canada and 3 more
- Volunteers
- 147 people
- Sponsor
- InSightec
Leiomyoma
Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids
The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment. Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid tissue in pre…
- Trial name
- NCT00131365
- Testing
- ExAblate 2000
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- InSightec
Uterine Fibroids
Safety Study of ExAblate for the Treatment of Uterine Fibroids
The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines.
- Trial name
- NCT01142791
- Testing
- ExAblate
- Where
- 8 sites in United States
- Volunteers
- 121 people
- Sponsor
- InSightec
Bone Cancer, Bone Metastases
Study Comparing the Safety and Effectiveness of Magnetic Resonance Guided Focused Ultrasound (MRgFUS) and External Beam Radiation (EBRT) for Treatment of Metastatic Bone Tumors and Multiple Myeloma
The goal of this study is to collect comparative data on safety and efficacy of MR Guided Focused Ultrasound and External Beam Radiation for treatment of metastatic bone tumors or multiple myeloma.
- Conditions
- Bone Cancer, Bone Metastases, Pain
- Trial name
- NCT01091883
- Testing
- Exablate treatment, Radiation
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- InSightec
Localized Low-Intermediate Risk Prostate Cancer
Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study
The hypothesis of this feasibility study is that focal treatment with ExAblate MRgFUS has the potential to be a safe and effective non-invasive treatment for low to intermediate risk, organ-confined prostate cancer involving low…
- Trial name
- NCT01226576
- Testing
- MRgFUS Treatment
- Where
- 5 sites in Canada, Israel and 3 more
- Volunteers
- 8 people
- Sponsor
- InSightec
Uterine Fibroids
ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids
The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids.
- Trial name
- NCT01285960
- Testing
- ExAblate Treatment UF V2
- Where
- 8 sites in United States
- Volunteers
- 108 people
- Sponsor
- InSightec
Uterine Leiomyoma, Uterine Fibroids
MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication
This is a phase 3 study to determine the safety of the new features to the FDA approved ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.
- Trial name
- NCT00365989
- Testing
- ExAblate Enhanced Sonication
- Where
- 5 sites in United States, Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- InSightec
Uterine Fibroids, Uterine Leiomyomas
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation
The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment.
- Trial name
- NCT00295217
- Testing
- ExAblate 2000
- Where
- 4 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- InSightec
Pain Resulting From Bone Metastases
ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
The purpose of this enhanced surveillance study ("ESS") is to collect information regarding chronic adverse events that are possibly related to the ExAblate® System ("ExAblate") that are received by InSightec ("InSightec")…
- Trial name
- BM019-Registry (NCT01834937)
- Testing
- ExAblate MRgFUS (Magnetic Resonance guided Focused Ultrasound Surgery)
- Where
- 6 sites in United States
- Volunteers
- 17 people
- Sponsor
- InSightec