相关临床试验
86
17 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
16
18.6%
已完成
47
54.6%
尚未招募
1
1.2%
招募中
11
12.8%
暂停
1
1.2%
终止
7
8.1%
撤回
3
3.5%
暂无批准数据
- CU Anschutz clinicians performed the Rocky Mountain region's first dual-target HIFU procedures, targeting the DRTT and PTT tracts six to nine millimeters apart in two advanced Parkinson's patients. - The female patient achieved zero tremor and roughly 70% improvement in stiffness and movement speed after the PTT ablation, with benefits evident immediately on the MRI table. - An international trial published in Lancet Neurology reported 32% improvement in cardinal motor symptoms and 67% improvement in motor complications three months after bilateral PTT treatment. - Adverse events occurred in 39% of participants after unilateral treatment and 55% after bilateral treatment, prompting calls for rigorous patient selection and counseling.
- A 40-year-old Israeli man with an extreme opioid dependence of approximately 130 pills daily was successfully detoxed in a single 20-minute noninvasive brain procedure at Rambam Health Care Campus. - The treatment uses Insightec's focused ultrasound technology to modulate the nucleus accumbens without heating or damaging tissue, targeting the brain's reward and craving circuitry. - One week post-treatment, the patient tested negative for opioids and reported a craving score of zero out of 10, with an unexpected cessation of heavy smoking and alcohol urges. - The procedure is part of an international multicenter trial across three U.S. centers and Rambam, with researchers calling it a potential platform for treating PTSD, OCD, depression, and other disorders.
- Insightec has spun out Lotus Neuro, a clinical-stage biotechnology company focused on advancing brain-targeted therapeutics using precision, low-frequency focused ultrasound technology. - The new company will initially target neuro-oncology programs including glioblastoma and diffuse midline gliomas, while developing partnerships in neurodegeneration. - Lotus Neuro builds on Insightec's proven platform that has treated over 25,000 patients and recently demonstrated improved survival outcomes in glioblastoma trials. - The spin-out is funded by Nexus NeuroTech Ventures and will be led by Dr. Arjun Desai, former Chief Strategic Innovation Officer at Insightec.
- Rhode Island Hospital has become the first institution in the United States to enroll patients in a groundbreaking clinical trial combining focused ultrasound with immunotherapy to treat brain metastases from lung cancer. - The innovative approach uses non-invasive sound waves to temporarily open the blood-brain barrier, allowing immunotherapy drugs to better penetrate brain tumors that are typically protected by this natural shield. - Brain metastases affect an estimated one in four patients with lung cancer, with over 98% of current drugs unable to cross the blood-brain barrier, leaving patients with limited treatment options beyond surgery and radiation. - The randomized trial will compare immunotherapy alone versus the combination of focused ultrasound plus immunotherapy, with treatments administered six times over three-week intervals across seven institutions worldwide.
- The FDA has approved Insightec's Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients with advanced Parkinson's disease, expanding therapeutic options for over 50,000 patients. - The incisionless procedure uses MRI-guided focused ultrasound to precisely target brain areas without requiring implanted hardware, offering a lower risk profile compared to traditional surgical interventions. - Clinical trials conducted at nine centers across the U.S., Europe, and Asia demonstrated encouraging outcomes supporting FDA approval, with full results expected to be published later this year. - Insightec plans a limited launch of the bilateral procedure in select centers during 2025, with ongoing efforts to establish routine reimbursement pathways for broader patient access.
- Comprehensive genomic profiling is crucial for brain cancer patients, enabling personalized treatment approaches and identification of actionable mutations like NTRK fusions, according to Dr. Manmeet Ahluwalia. - The recent FDA approval of vorasidenib (Voranigo) for IDH-mutant gliomas represents a breakthrough in targeted therapy for brain tumors and provides hope for developing additional brain-penetrating drugs. - Clinical trials remain the optimal treatment option for aggressive brain cancers like glioblastoma, with increasing availability in both academic centers and larger community practices.
- Insightec's Exablate Prime system has gained FDA approval and CE mark for integration with select Philips MRI systems, expanding access to non-invasive treatments. - The approval covers Philips 1.5T and 3.0T Ingenia systems, Ambition 1.5T, Elition 3.0T, and MR 7700 3.0T, enhancing treatment options for patients. - Exablate Prime uses MRI-guided focused ultrasound for tremor treatment in medication-refractory essential tremor and Parkinson’s disease patients, offering immediate improvement. - With over 160 systems installed globally and nearly 20,000 commercial applications, this collaboration aims to broaden the availability of cutting-edge care.
- Insightec's Exablate Prime system has been approved by the FDA and has received CE Mark for integration with select Philips MRI systems, expanding access to focused ultrasound treatments. - The Exablate Prime system is now compatible with Philips 1.5T and 3.0T Ingenia systems, Philips Ambition 1.5T, Philips Elition 3.0T, as well as Philips MR 7700 3.0T. - Focused ultrasound, pioneered by Insightec, is an FDA-approved and CE Marked treatment for essential tremor and some Parkinson's disease symptoms, performed in a single outpatient procedure.
- A multi-center clinical trial demonstrates the safety and efficacy of bilateral high-intensity focused ultrasound for essential tremor. - The study, published in JAMA Neurology, showed that second-side treatment is effective with mostly mild side effects. - FDA approved the procedure for the non-dominant side in 2023, expanding treatment options for essential tremor patients. - Patients report significant improvements in quality of life, regaining control in both hands for daily activities.
- The FDA has approved Insightec's Exablate Neuro focused ultrasound system for treating advanced Parkinson's disease patients with mobility, rigidity, or dyskinesia symptoms through incisionless pallidotomy. - The treatment uses focused ultrasound waves to precisely target and ablate the globus pallidus without requiring brain implants or surgical incisions, reducing infection risk compared to invasive surgery. - This approval expands the device's indications beyond essential tremor and tremor-dominant Parkinson's disease, with 37 medical centers in the US currently using the technology. - Parkinson's disease affects an estimated one million patients in the United States, with the new approval providing a less invasive surgical option when medications are not well tolerated.
