NCT07178210招募中不适用
Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - A Global, Prospective, Early Feasibility Study in Alzheimer's Patients
MMI (Medical Microinstruments, Inc.)3 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年4月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Device-related serious adverse events at 30-days
研究概览
简要总结
The objective of this investigational device exemption (IDE) study is to evaluate the safety and feasibility of using the Symani System and microsurgical techniques in the deep cervical lymph node (dCLN) region in the setting of mild to moderate Alzheimer's disease and lymphatic abnormalities.
详细描述
A prospective, multi-center, early feasibility study, designed to evaluate the Symani System's safety and feasibility for performing microsurgical techniques in the dCLN region to improve clearance of neurotoxins, such as amyloid-beta and phosphorylated tau, in patients with confirmed mild to moderate Alzheimer's disease and lymphatic abnormalities in the dCLN region.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 to 80 years of age
- •Patients who are of childbearing potential must agree to use a medically acceptable form of contraception for the duration of the study
- •Patient has confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria
- •Patient has a positive amyloid PET test and/or a positive CSF t-tau/amyloid-beta-42 test
- •Patient has an MMSE score within the mild to moderate range (21-26 and 10-20)
- •Patient has CDR-SB score within the mild to moderate range; mild is 4.5to 9.0 and moderate is 9.5 to 15.5
- •Patient has confirmed extracranial lymphatic abnormalities in the head and neck region as identified by preoperative imaging
- •Investigator deems the candidate acceptable for lymphatic surgery with a robotic-assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU)
- •Patient or their legally authorized representative agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure
排除标准
- •Patient (or their legally authorized representative) is unwilling to provide informed consent
- •Patient has suspected dementia of other type, e.g., Lewy body, frontotemporal disorder, vascular, etc.
- •Patient has documented or suspected neurological or intracranial conditions such as cerebrovascular accident, tumors, intracranial space occupying lesions, seizures or other intracranial/neurological conditions that may affect their safety in the study.
- •History of head and neck radiation exposure
- •Patient with severe kidney disease (GFR <30 mL/min/1.73m2)
- •Patient with acute kidney injury
- •Active systemic infection under treatment with intravenous antibiotics
- •Patient has a modified Rankin Score (mRS) of >4
- •Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, untreated sleep apnea, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigator's discretion
- •Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
- •Patient with an active cancer diagnosis and/or currently receiving treatment for cancer or has received treatment within the past 6 months
- •Patient is currently receiving treatment or has been treated with anti-amyloid-beta monoclonal antibody therapy within the past 3 months
- •Patient has contraindication for MRI or intrathecal administration of gadobutrol
- •Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or study outcomes
- •Patient is ineligible to participate for other reasons in the judgment of the investigator
研究组 & 干预措施
Alzheimer's Disease
Experimental
Patient with confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria
干预措施: Symani Surgical System (Device)
结局指标
主要结局
Device-related serious adverse events at 30-days
时间窗: The duration of the participants' index procedure through 30-days post index procedure.
All intraoperative and postoperative device-related serious adverse events (SAEs) will be captured from the start of the index procedure through 30 days post-index procedure for each participant. The device-related SAE rate will be reported at 30 days post-index procedure for all evaluable participants.
次要结局
- Rate of Serious Adverse Events (SAEs) at 6 months(The duration of the participants' index procedure through 6-months post index procedure.)
- Rate of Adverse Events (AEs) at 30 days(The duration of the participants' index procedure through 30-days post index procedure.)
- Anastomosis-Specific Reoperation Rate at 30 Days(The duration of the participants' index procedure through 30-days post index procedure.)
- Change in Amyloid PET Centiloid Value at 6 Months(The duration of the participants' pre-procedure visit through 6-months post index procedure.)
- Change in Plasma Biomarkers at 6 Months: amyloidβ-42 and 40, ptau-217, NfL and GFAP(The duration of the participants' pre-procedure visit through 6-months post index procedure.)
- Anastomosis Patency Prior to Closure(The duration of the participants' index procedure.)
- Intraoperative Conversion to Manual Approach(The duration of the participants' index procedure.)
研究者
研究点 (3)
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