Early Feasibility Clinical Study of the VitalFlow Stimulator, an Emergency Treatment for Ischemic Stroke
VitalFlow 刺激器(缺血性中风的紧急治疗)的早期可行性临床研究
基本信息
- 批准号:9785632
- 负责人:
- 金额:$ 94.09万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2017
- 资助国家:美国
- 起止时间:2017-08-01 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:Accident and Emergency departmentAcuteAlteplaseArteriesBlood PreservationBlood coagulationBlood flowBrainBrain InjuriesBrain regionCanis familiarisCathetersCause of DeathCerebrovascular CirculationClinicalClinical ResearchCoagulation ProcessComplementContractsDevelopmentDevice DesignsDevicesDiffuseEarEffectivenessEmergency treatmentEnrollmentEquipmentEuropeEuropeanFacial nerve structureFeedbackFreezingGoalsGrantHealthcareHospital CostsHospitalsHourInfusion proceduresInjuryInstitutional Review BoardsIntracranial HemorrhagesIntravenousIschemic StrokeLifeMagnetismMedical DeviceMissionModificationNational Institute of Neurological Disorders and StrokeNerveOhioOryctolagus cuniculusOutcomePatient-Focused OutcomesPatientsPhasePhysiologic pulseProtocols documentationQuality ControlRandomized Controlled TrialsRecording of previous eventsRegulatory PathwayResearch PersonnelRetrievalRuptureSafetySalesSavingsSiteStrokeSystemTestingTherapeuticTrainingVasospasmWritingbasebrain tissuecerebral arterycommercial applicationdesigndisabilityexperimental studyimprovedinnovationmeetingsnew technologyperformance testspreventprototypestandard of carestroke modelstroke patientsuccess
项目摘要
Stroke is the world’s greatest healthcare burden for which few treatment options are available. The long-term
objective of the applicant, Nervive, Inc., is to bring to market a non-invasive medical device, the VitalFlow
stimulator, as an emergency treatment for ischemic stroke. The VitalFlow is a novel technology that activates
the autonomic components of the facial nerve using pulsed magnetic energy, thereby dilating the arteries of
the brain and increasing cerebral blood flow (CBF). Delivery of intravenous tissue plasminogen activator (rtPA)
to the site of an obstructing blood clot will be improved by increasing CBF, and endovascular clot retrieval
catheter navigation will be facilitated by dilation of the cerebral arteries. Thus, the VitalFlow stimulator is highly
relevant to the mission of the NINDS because it seeks to improve clinical outcomes in stroke patients and
reduce the burden of stroke.
With CREATE Devices grant support, we intend to test a clinical prototype VitalFlow stimulator that can be
used in the emergency department for the treatment of acute ischemic stroke. The following Specific Aims are
proposed:
In Phase I of the CREATE Devices project, Nervive will achieve the following:
Specific Aim 1: Write the Early Feasibility Clinical Study protocol.
Specific Aim 2: Establish a Quality Control System and freeze VitalFlow device design.
Specific Aim 3: Complete a Pre-IDE meeting with FDA.
In Phase II of the CREATE Devices project, Nervive will achieve the following:
Specific Aim 4: Complete external performance testing of the VitalFlow stimulator.
Specific Aim 5: Receive FDA IDE clearance and hospital IRB approval.
Specific Aim 6: Conduct an Early Feasibility Clinical Study in 8 acute ischemic stroke patients.
Nervive is pursuing Expedited Access Pre-Market Approval (PMA) regulatory clearance for the VitalFlow. In
the U.S. alone, the commercial opportunity for the VitalFlow includes the sale of device hardware to 5700
hospitals and the sale of consumable components for more than 400k patient treatments each year.
中风是世界上最大的医疗负担,几乎没有可用的治疗方案。长期的
申请者Nervive,Inc.的目标是将一种非侵入性医疗设备VitalFlow推向市场
刺激器,作为缺血性中风的紧急治疗。VitalFlow是一项新技术,它可以激活
面神经的自主神经成分使用脉冲磁能,从而扩张动脉
和增加脑血流量(CBF)。静脉注射组织型纤溶酶原激活剂(RtPA)
通过增加脑血流量和血管内血栓回收,阻塞的血栓部位将得到改善。
通过扩张大脑动脉,导管导航将变得更容易。因此,VitalFlow刺激器是高度
与NINDS的使命相关,因为它寻求改善中风患者的临床结果,并
减轻中风的负担。
在Create Devices的赠款支持下,我们打算测试一种临床原型VitalFlow刺激器,它可以
用于急诊科治疗急性缺血性中风。以下是具体目标
建议:
在Create Devices项目的第一阶段,Nervive将实现以下目标:
具体目标1:编写早期可行性临床研究方案。
具体目标2:建立质量控制体系,冻结VitalFlow装置设计。
具体目标3:完成与FDA的集成前会议。
在Create Devices项目的第二阶段,Nervive将实现以下目标:
具体目标4:完成VitalFlow刺激器的外部性能测试。
具体目标5:获得FDA IDE批准和医院IRB批准。
具体目标6:对8例急性缺血性卒中患者进行早期可行性临床研究。
Nervive正在为VitalFlow寻求快速接入上市前批准(PMA)监管审批。在……里面
仅在美国,VitalFlow的商业机会就包括向5700销售设备硬件
医院和销售消耗性组件,每年治疗40多万名患者。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
STEPHANIE ADI HARRINGTON其他文献
STEPHANIE ADI HARRINGTON的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('STEPHANIE ADI HARRINGTON', 18)}}的其他基金
Miniaturized Distal Vibration System for Penetration of Vascular Occlusions
用于穿透血管闭塞的小型化远端振动系统
- 批准号:
7909616 - 财政年份:2010
- 资助金额:
$ 94.09万 - 项目类别:
相似海外基金
Transcriptional assessment of haematopoietic differentiation to risk-stratify acute lymphoblastic leukaemia
造血分化的转录评估对急性淋巴细胞白血病的风险分层
- 批准号:
MR/Y009568/1 - 财政年份:2024
- 资助金额:
$ 94.09万 - 项目类别:
Fellowship
Combining two unique AI platforms for the discovery of novel genetic therapeutic targets & preclinical validation of synthetic biomolecules to treat Acute myeloid leukaemia (AML).
结合两个独特的人工智能平台来发现新的基因治疗靶点
- 批准号:
10090332 - 财政年份:2024
- 资助金额:
$ 94.09万 - 项目类别:
Collaborative R&D
Acute senescence: a novel host defence counteracting typhoidal Salmonella
急性衰老:对抗伤寒沙门氏菌的新型宿主防御
- 批准号:
MR/X02329X/1 - 财政年份:2024
- 资助金额:
$ 94.09万 - 项目类别:
Fellowship
Cellular Neuroinflammation in Acute Brain Injury
急性脑损伤中的细胞神经炎症
- 批准号:
MR/X021882/1 - 财政年份:2024
- 资助金额:
$ 94.09万 - 项目类别:
Research Grant
STTR Phase I: Non-invasive focused ultrasound treatment to modulate the immune system for acute and chronic kidney rejection
STTR 第一期:非侵入性聚焦超声治疗调节免疫系统以治疗急性和慢性肾排斥
- 批准号:
2312694 - 财政年份:2024
- 资助金额:
$ 94.09万 - 项目类别:
Standard Grant
Combining Mechanistic Modelling with Machine Learning for Diagnosis of Acute Respiratory Distress Syndrome
机械建模与机器学习相结合诊断急性呼吸窘迫综合征
- 批准号:
EP/Y003527/1 - 财政年份:2024
- 资助金额:
$ 94.09万 - 项目类别:
Research Grant
FITEAML: Functional Interrogation of Transposable Elements in Acute Myeloid Leukaemia
FITEAML:急性髓系白血病转座元件的功能研究
- 批准号:
EP/Y030338/1 - 财政年份:2024
- 资助金额:
$ 94.09万 - 项目类别:
Research Grant
KAT2A PROTACs targetting the differentiation of blasts and leukemic stem cells for the treatment of Acute Myeloid Leukaemia
KAT2A PROTAC 靶向原始细胞和白血病干细胞的分化,用于治疗急性髓系白血病
- 批准号:
MR/X029557/1 - 财政年份:2024
- 资助金额:
$ 94.09万 - 项目类别:
Research Grant
ロボット支援肝切除術は真に低侵襲なのか?acute phaseに着目して
机器人辅助肝切除术真的是微创吗?
- 批准号:
24K19395 - 财政年份:2024
- 资助金额:
$ 94.09万 - 项目类别:
Grant-in-Aid for Early-Career Scientists
Acute human gingivitis systems biology
人类急性牙龈炎系统生物学
- 批准号:
484000 - 财政年份:2023
- 资助金额:
$ 94.09万 - 项目类别:
Operating Grants