Clinical trials: sponsored by 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
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
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
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
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
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
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
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, With Unexplained Infertility
ExAblate Treatment of Uterine Fibroids for Fertility Enhancement
The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000 system for enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids, who are diagnosed with unexplained…
- Trial name
- NCT00730886
- Testing
- ExAblate 2000, Myomectomy
- Where
- 6 sites in United States
- Volunteers
- 2 people
- Sponsor
- InSightec