Clinical trials: sponsored by 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
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
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
Uterine Fibroids, Bleeding
Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids
The objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids. Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to…
- Conditions
- Uterine Fibroids, Bleeding, Pelvic Pain
- Trial name
- NCT01328067
- Testing
- Exablate 2100, Myomectomy
- Where
- United Kingdom
- 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
Bone Metastases
MR Guided Focused Ultrasound Surgery in the Treatment of Pain From Bone Tumors w/ the ExAblate 2000 Strappable System
A Feasibility Study To Evaluate the Safety and initial Effectiveness of MR guided Focused Ultrasound Surgery in the Treatment of pain resulting from Metastatic Bone Tumors with the ExAblate 2000 strappable system.
- Trial name
- BM005 (NCT03547557)
- Testing
- Exablate 2000 strappable system
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- InSightec
Essential Tremor
ExAblate Transcranial MR Guided Focused Ultrasound in the Treatment of Essential Tremor
A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MRI-guided focused ultrasound (MRgFUS) treatment of patients with medication-refractory movement disorders, namely Essential Tremor (ET).
- Trial name
- NCT02037217
- Testing
- ExAblate Transcranial MRgFUS System
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- InSightec
Prostate Cancer
Safety Evaluation of ExAblate MRgFUS for Prostate Cancer
Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.
- Trial name
- NCT00811265
- Testing
- ExAblate MRgFUS for prostate cancer
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- InSightec
Bone Cancer, Bone Metastases
Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System
The goal of this prospective, non-randomized, single-arm, phase 2 study is to evaluate the safety and effectiveness of this treatment using this ExAblate conformal system in the treatment of pain resulting from metastatic bone…
- Conditions
- Bone Cancer, Bone Metastases, Pain
- Trial name
- NCT01085565
- Testing
- ExAblate 2100
- Where
- Israel
- Volunteers
- 50 people
- Sponsor
- InSightec
Tremor, Essential Tremor
ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) for Treatment of Tremor
A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor
- Trial name
- NCT01932463
- Testing
- ExAblate Transcranial System
- Where
- Canada
- Volunteers
- 6 people
- Sponsor
- InSightec
Essential Tremor
ExAblate Transcranial MR Guided Focused Ultrasound in the Treatment of Essential Tremor
The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the brain of patients suffering from medication-refractory Essential Tremor…
- Trial name
- NCT01304758
- Testing
- ExAblate Transcranial MRgFUS System
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- InSightec
Bone Metastases
MR Guided Focused Ultrasound Surgery of Metastatic Bone Tumors
The objective of this trial is to evaluate the safety and effectiveness of MRgFUS in the treatment of metastatic bone tumors.
- Trial name
- NCT00350233
- Testing
- ExAblate 2000
- Where
- 2 sites in United States, Canada
- Volunteers
- 10 people
- Sponsor
- InSightec