InSightec — Biomedical Watch V2

Traitements8programmes

Essais3liés

Publications6liées

SourceDBlocale

Traitements

8

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Best Medical Treatment (BMT)This study is a randomized clinical trial evaluating a focused ultrasound treatment for people with advanced Parkinson's disease (PD) who have disabling motor complications and symptoms. The study uses the Exablate Neuro System, which delivers MR-guided Focused Ultrasound (MRgFUS). This technology focuses ultrasound energy on a specific brain target and generates heat to create a small lesion (ablation) without making a surgical incision. The target in this study is the Pallidothalamic Tract (PTT), a pathway involved in the abnormal brain circuits that contribute to Parkinson's symptoms and complications. This study is evaluating whether treating one side of the brain or treating both sides (in separate procedures) provides better outcomes for people with advanced Parkinson's disease who have motor complications and symptoms. The main outcome measure is the change in the MDS-UPDRS Part III Upper/Lower Extremity (ULE) score at 3 months after first and second side treatment, compared with the respective control groups. MDS-UPDRS Part III is a standard clinical scale used to assess Parkinson's motor symptoms. ULE score focuses on motor function in the arms and legs. Assessments are performed in the OFF-medication state, meaning Parkinson's medications are temporarily withheld so that the treatment effect can be measured more accurately. In addition improvement in motor complications will be assessed with MDS-UPDRS Part IV and Patient diaries.	Parkinson	Non applicable	Traitement symptomatique		À vérifier
Exablate Prostate TreatmentThis extended clinical investigation is a multicenter, prospective, single arm study intended to provide continued access of the Exablate Model 2100 device (Exablate Prostate) to patients for treatment of prostate lesions and collect additional safety and effectiveness data during the 510(k) preparation and review period.	Cancer	Non applicable	À vérifier	United States	À vérifier
ExAblate Transcranial SystemThis is primarily a safety protocol to evaluate the safety of subthalamotomy using Transcranial ExAblate for treatment of Parkinson's Disease (PD) motor features.	Parkinson	Non applicable	À vérifier	United States	À vérifier
Staged Bilateral Exablate Pallidothalamic TractotomyThis study is a randomized clinical trial evaluating a focused ultrasound treatment for people with advanced Parkinson's disease (PD) who have disabling motor complications and symptoms. The study uses the Exablate Neuro System, which delivers MR-guided Focused Ultrasound (MRgFUS). This technology focuses ultrasound energy on a specific brain target and generates heat to create a small lesion (ablation) without making a surgical incision. The target in this study is the Pallidothalamic Tract (PTT), a pathway involved in the abnormal brain circuits that contribute to Parkinson's symptoms and complications. This study is evaluating whether treating one side of the brain or treating both sides (in separate procedures) provides better outcomes for people with advanced Parkinson's disease who have motor complications and symptoms. The main outcome measure is the change in the MDS-UPDRS Part III Upper/Lower Extremity (ULE) score at 3 months after first and second side treatment, compared with the respective control groups. MDS-UPDRS Part III is a standard clinical scale used to assess Parkinson's motor symptoms. ULE score focuses on motor function in the arms and legs. Assessments are performed in the OFF-medication state, meaning Parkinson's medications are temporarily withheld so that the treatment effect can be measured more accurately. In addition improvement in motor complications will be assessed with MDS-UPDRS Part IV and Patient diaries.	Parkinson	Non applicable	Traitement symptomatique		À vérifier
Unilateral Exablate MRgFUS Pallidothalamic TractotomyThis study is a randomized clinical trial evaluating a focused ultrasound treatment for people with advanced Parkinson's disease (PD) who have disabling motor complications and symptoms. The study uses the Exablate Neuro System, which delivers MR-guided Focused Ultrasound (MRgFUS). This technology focuses ultrasound energy on a specific brain target and generates heat to create a small lesion (ablation) without making a surgical incision. The target in this study is the Pallidothalamic Tract (PTT), a pathway involved in the abnormal brain circuits that contribute to Parkinson's symptoms and complications. This study is evaluating whether treating one side of the brain or treating both sides (in separate procedures) provides better outcomes for people with advanced Parkinson's disease who have motor complications and symptoms. The main outcome measure is the change in the MDS-UPDRS Part III Upper/Lower Extremity (ULE) score at 3 months after first and second side treatment, compared with the respective control groups. MDS-UPDRS Part III is a standard clinical scale used to assess Parkinson's motor symptoms. ULE score focuses on motor function in the arms and legs. Assessments are performed in the OFF-medication state, meaning Parkinson's medications are temporarily withheld so that the treatment effect can be measured more accurately. In addition improvement in motor complications will be assessed with MDS-UPDRS Part IV and Patient diaries.	Parkinson	Non applicable	Traitement symptomatique		À vérifier
ExAblate Transcranial SystemThis is primarily a safety protocol to evaluate the safety of subthalamotomy using Transcranial ExAblate for treatment of Parkinson's Disease (PD) motor features.	Parkinson	Non applicable	À vérifier	United States	À vérifier
Unilateral Exablate MRgFUS Pallidothalamic TractotomyThis study is a randomized clinical trial evaluating a focused ultrasound treatment for people with advanced Parkinson's disease (PD) who have disabling motor complications and symptoms. The study uses the Exablate Neuro System, which delivers MR-guided Focused Ultrasound (MRgFUS). This technology focuses ultrasound energy on a specific brain target and generates heat to create a small lesion (ablation) without making a surgical incision. The target in this study is the Pallidothalamic Tract (PTT), a pathway involved in the abnormal brain circuits that contribute to Parkinson's symptoms and complications. This study is evaluating whether treating one side of the brain or treating both sides (in separate procedures) provides better outcomes for people with advanced Parkinson's disease who have motor complications and symptoms. The main outcome measure is the change in the MDS-UPDRS Part III Upper/Lower Extremity (ULE) score at 3 months after first and second side treatment, compared with the respective control groups. MDS-UPDRS Part III is a standard clinical scale used to assess Parkinson's motor symptoms. ULE score focuses on motor function in the arms and legs. Assessments are performed in the OFF-medication state, meaning Parkinson's medications are temporarily withheld so that the treatment effect can be measured more accurately. In addition improvement in motor complications will be assessed with MDS-UPDRS Part IV and Patient diaries.	Parkinson	Non applicable	Traitement symptomatique		À vérifier
Exablate Prostate TreatmentThis extended clinical investigation is a multicenter, prospective, single arm study intended to provide continued access of the Exablate Model 2100 device (Exablate Prostate) to patients for treatment of prostate lesions and collect additional safety and effectiveness data during the 510(k) preparation and review period.	Cancer	Non applicable	À vérifier	United States	À vérifier

Essais cliniques

3

Molécule	Indication / population	Phase	NCT	Titre	Statut
Exablate Prostate Treatment	Cancer	Non applicable	NCT03998657	Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions	ACTIVE_NOT_RECRUITING
Unilateral Exablate MRgFUS Pallidothalamic Tractotomy	Parkinson	Non applicable	NCT07764874	FREEDOM — Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease.	NOT_YET_RECRUITING
ExAblate Transcranial System	Parkinson	Non applicable	NCT02246374	ExAblate Transcranial MRgFUS of the Subthalamic Nucleus for Treatment of Parkinson's Disease	COMPLETED

Publications

6

Molécule	Indication / population	Titre	Journal	Date
Best Medical Treatment (BMT)		Distal Vessel Occlusions in Acute Ischemic Stroke: Reframing Patient Selection and Reperfusion Strategies.	Neurology
Best Medical Treatment (BMT)		Subcutaneous foslevodopa/foscarbidopa (LDp/CDp) in advanced Parkinson's disease (aPD): societal cost impact analysis for the UK, France, Germany, Spain, and Canada.	Journal of medical economics
Best Medical Treatment (BMT)		Endovascular thrombectomy versus best medical therapy for acute vertebrobasilar artery occlusion in patients with low NIHSS scores: a meta-analysis.	Annals of medicine
ExAblate Transcranial System		Comparison between MR and CT imaging used to correct for skull-induced phase aberrations during transcranial focused ultrasound.	Scientific reports
ExAblate Transcranial System		Hybrid surgery of ventral intermediate nucleus thalamotomy using magnetic resonance-guided focus ultrasound and modulation by deep brain stimulation controls bilateral essential tremor.	Journal of rural medicine : JRM
ExAblate Transcranial System		Cavitation Feedback Control of Focused Ultrasound Blood-Brain Barrier Opening for Drug Delivery in Patients with Parkinson's Disease.	Pharmaceutics