Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

Официальное название

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - A Global, Prospective, Early Feasibility Study in Alzheimer's Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Symani Surgical System
  Use of Symani Surgical System for performing microsurgical techniques in the deep cervical lymph nodes.

Первичные конечные точки

• Device-related serious adverse events at 30-days [Срок оценки: The duration of the participants' index procedure through 30-days post index procedure.]

Вторичные конечные точки (7)

• Rate of Serious Adverse Events (SAEs) at 6 months [Срок оценки: The duration of the participants' index procedure through 6-months post index procedure.]
• Rate of Adverse Events (AEs) at 30 days [Срок оценки: The duration of the participants' index procedure through 30-days post index procedure.]
• Anastomosis-Specific Reoperation Rate at 30 Days [Срок оценки: The duration of the participants' index procedure through 30-days post index procedure.]
• Change in Amyloid PET Centiloid Value at 6 Months [Срок оценки: 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 [Срок оценки: The duration of the participants' pre-procedure visit through 6-months post index procedure.]
• Anastomosis Patency Prior to Closure [Срок оценки: The duration of the participants' index procedure.]
• Intraoperative Conversion to Manual Approach [Срок оценки: The duration of the participants' index procedure.]

Критерии участия

Критерии включения

• Patient aged 50 or older
• 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

Критерии исключения

• 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, 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Stanford Medical Center — Palo Alto
• Baptist Health Research Institute — Jacksonville

Идентификаторы

NCT: NCT07178210 · CDC-00157

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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