Clinical trials: completed, sponsored by 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
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
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
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, 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
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
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
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
Uterine Fibroids
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
This is a prospective, nonrandomized, multi-center study to evaluate the safety and effectiveness of ExAblate in the treatment of uterine fibroids.
- Trial name
- NCT00166270
- Testing
- ExAblate 2000
- Where
- 6 sites in United States
- Volunteers
- 70 people
- Sponsor
- InSightec
Alzheimer Disease
Blood-Brain-Barrier Opening Using Focused Ultrasound With IV Contrast Agents in Patients With Early Alzheimer's Disease
This is a prospective, non-randomized, single-arm, feasibility study to evaluate the safety and initial effectiveness of opening of the Blood-Brain Barrier with intravenous contrast agents using the ExAblate Neuro System in…
- Trial name
- BBB-Alzheimers (NCT02986932)
- Testing
- BBB opening
- Where
- Canada
- Volunteers
- 6 people
- Sponsor
- InSightec