52 completed, 14 active not recruiting, 10 recruiting, 8 terminated. 68 Not applicable, 9 Phase 2, 8 Phase 1, 4 Phase 3, 2 Early Phase 1.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| High-Intensity Focused Ultrasonic Ablation of the Centromedian Thalamic Nucleus for Treatment of Medically Refractory Generalized Epilepsy in Patients Ages 18 Years to 89 Years Intervention 1, Intervention 2 - Idiopathic Generalized Epilepsy | Not applicable | Not yet recruiting | Oregon Health and Science University | 10 | 2027-02-01 | 2026-10-28 |
| Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease. Unilateral Exablate MRgFUS Pallidothalamic Tractotomy, Staged Bilateral Exablate Pallidothalamic Tractotomy, Best Medical Treatment (BMT) - Parkinson Disease | Not applicable | Not yet recruiting | InSightec | 120 | 2026-11-01 | 2026-11-06 |
| EMBRACE Tremor BiFUS Staged bilateral Exablate thalamotomy, Local standard medical treatment after previous Exablate unilateral thalamotomy. - Essential Tremor | Not applicable | Recruiting | InSightec | 100 | 2025-04-22 | 2026-08-31 |
| Safety and Effectiveness of Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma Exablate BBBD - Glioma | Not applicable | Withdrawn | InSightec | 2024-10-23 | 2025-05-02 | |
| A Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound Subthalamotomy in Patients With Early-Stage Parkinson's Disease Exablate MRgFUS subthalamotomy, Best Medical Treatment - Parkinson Disease | Not applicable | Active not recruiting | InSightec | 67 | 2024-08-01 | 2026-05-06 |
| Randomized Study of Neo-adjuvant and Adjuvant Pembrolizumab With and Without Targeted Blood Brain Barrier Opening Using Exablate MRI-guided Focused Ultrasound (Exablate MRgFUS) for Recurrent Glioblastoma Pembrolizumab, Exablate MRgFUS + neoadjuvant pembolizumab - Recurrent Glioblastoma | Phase 2 | Withdrawn | M.D. Anderson Cancer Center | 2024-07-30 | 2024-11-20 | |
| MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD) ExAblate Transcranial treatment - Task-Specific Focal Dystonia | Not applicable | Recruiting | University of Maryland, Baltimore | 10 | 2024-06-10 | 2026-02-27 |
| Focused Ultrasound for Drug-resistant Epilepsy Exablate 4000 Transcranial MRgfUS System - Focused Ultrasound, MR-guided FUS | Not applicable | Recruiting | Taipei Veterans General Hospital, Taiwan | 10 | 2024-01-01 | 2026-10-16 |
| ExAblate Blood Brain Barrier Disruption (BBBD) for Planned Surgery in Suspected Infiltrating Glioma ExAblate 4000 - Type 2 - Glioma | Not applicable | Suspended | InSightec | 15 | 2023-10-01 | 2022-08-03 |
| Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) Exablate Model 4000 Type 2.0/2.1 - Opioid Use Disorder | Not applicable | Completed | West Virginia University | 5 | 2023-09-19 | 2025-07-20 |
| 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 Exablate Pallidotomy, Unilateral - Movement Disorders, Neurology | Recruiting | InSightec | 60 | 2023-01-23 | 2026-03-20 | |
| Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG) Exablate, Doxorubicin - Brain Tumor | Phase 1 / Phase 2 | Active not recruiting | InSightec | 10 | 2023-01-04 | 2026-04-17 |
| Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG Exablate, Doxorubicin - Brain Tumor | Phase 1 / Phase 2 | Active not recruiting | InSightec | 10 | 2023-01-04 | 2026-04-21 |
| Echo-Focusing in Patients With Treatment-Resistant Neurologic and Psychiatric Indications (EF001) Exablate Neuro Type 1.0 System with Echo Focusing - Essential Tremor, Neurology | Not applicable | Withdrawn | InSightec | 2022-12-31 | 2026-04-27 | |
| MR-guided Focused Ultrasound Plus GCase Blood Brain Barrier Disruption - Functional - Parkinsons Disease | Not applicable | Active not recruiting | InSightec | 14 | 2022-11-30 | 2026-11-04 |
| Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets Blood Brain Barrier Opening - Oncology, Pembrolizumab, Atezolizumab - Brain Tumor, Non Small Cell Lung Cancer | Phase 3 | Recruiting | InSightec | 96 | 2022-08-12 | 2026-10-13 |
| Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors Focused Ultrasound (Exablate Model 4000) - Glioblastoma, Glioma | Not applicable | Completed | InSightec | 71 | 2022-08-08 | 2025-07-28 |
| Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment or Mild Alzheimer's Disease Undergoing Standard of Care Monoclonal Antibody (mAb) Therapy Aducanumab, Exablate Model 4000 Type 2, Lecanemab - Mild Cognitive Impairment, Alzheimer Disease 1 | Early Phase 1 | Active not recruiting | Ali Rezai | 15 | 2022-07-14 | 2026-01-22 |
| 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 Unilateral thalamotomy - Tremor Associated With Tremor Dominant Parkinson's Disease | Recruiting | InSightec | 50 | 2022-04-28 | 2026-03-20 | |
| Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption in GBM Patients Magnetic Resonance guided Focused ultrasound (MRgFUS) - Glioma, Malignant, Glioblastoma | Completed | InSightec | 3 | 2021-08-25 | 2026-04-16 |
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Parkinson Disease (18) · Essential Tremor (14) · Leiomyoma (11) · Prostatic Neoplasms (10) · Breast Neoplasms (9) · Glioblastoma (9) · Brain Neoplasms (7) · Glioma (7) · Bone Neoplasms (6) · Lung Neoplasms (5) · Neoplasms (5) · Cancer Pain (4) · Neoplasm Metastasis (4) · Pain (4) · Alzheimer Disease (3)
Carboplatin (2) · Doxorubicin (2) · Uterine Myomectomy (2) · pembrolizumab (2) · High-Intensity Focused Ultrasound Ablation (1) · Nivolumab (1) · Pallidotomy (1) · Radiation (1) · aducanumab (1) · atezolizumab (1) · cemiplimab (1) · lecanemab (1)
United States (50) · Canada (26) · United Kingdom (10) · Israel (9) · South Korea (9) · Spain (9) · Japan (8) · Italy (7) · Taiwan (7) · China (4) · Germany (3) · Russia (2) · Chile (1) · Finland (1) · France (1)
Robert Min, M.D. (4) · George Holland, M.D. (3) · Graeme Woodworth, MD (3) · Anne Roberts, M.D. (2) · David Gianfelice, M.D. (2) · Fred Steinberg, M.D. (2) · Jin Woo Chang, Prof. (2) · Mark Shaman, M.D. (2) · Martin Bernstein (2) · Nir Lipsman, MD (2) · Ahmed Raslan, MD (1) · Ali Rezai, MD (1) · Ali Rezai, MD, FAANS (1) · Andres Lozano, MD (1) · Behfar Ehdaie, MD (1)
PMID 34815790, PMID 35995551, PMID 33693781, PMID 41308679, PMID 21570071, PMID 23283106, PMID 23944301, PMID 24760791, PMID 27557301, PMID 28747452, PMID 29084313, PMID 30519467, PMID 30674905, PMID 31748250, PMID 31899873, PMID 32651242, PMID 32815611, PMID 32858582, PMID 33014832, PMID 33369354, PMID 33399511, PMID 33481557, PMID 33510610, PMID 33536430, PMID 34504017, PMID 34859498, PMID 35714666, PMID 35765711, PMID 35932269, PMID 36334289, PMID 36631272, PMID 36694943, PMID 36812432, PMID 37328855, PMID 37553488, PMID 37722831, PMID 37947407, PMID 38157521, PMID 38227538, PMID 39073822, PMID 39212524, PMID 39798597, PMID 40892597, PMID 41296829, PMID 42309086
UH3DA047714-04S1 (1)