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Clinical Trials in the USA / NCT07178210
Recruiting Not applicable

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

NCT07178210 · tracked via the Priya Life Science USA tracker
Sponsor
MMI (Medical Microinstruments, Inc.)
Phase
Not applicable
Started
2026-04-30
Last updated
2026-08-24

Condition(s) studied

Alzheimer DiseaseLymphatic Obstruction

Investigational drug(s) / intervention(s)

Symani Surgical System

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

Study summary

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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. 50 to 80 years of age 2. Patients who are of childbearing potential must agree to use a medically acceptable form of contraception for the duration of the study 3. Patient has confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria 4. Patient has a positive amyloid PET test and/or a positive CSF t-tau/amyloid-beta-42 test 5. Patient has an MMSE score within the mild to moderate range (21-26 and 10-20) 6. 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 7. Patient has confirmed extracranial lymphatic abnormalities in the head and neck region as identified by preoperative imaging 8. 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) 9. 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 Exclusion Criteria: 1. Patient (or their legally authorized representative) is unwilling to provide informed consent 2. Patient has suspected dementia of other type, e.g., Lewy body, frontotemporal disorder, vascular, etc. 3. 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. 4. History of head and neck radiation exposure 5. Patient with severe kidney disease (GFR \<30 mL/min/1.73m2) 6. Patient with acute kidney injury 7. Active systemic infection under treatment with intravenous antibiotics 8. Patient has a modified Rankin Score (mRS) of \>4 9. 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 10. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease 11. Patient with an active cancer diagnosis and/or currently receiving treatment for cancer or has received treatment within the past 6 months 12. Patient is currently receiving treatment or has been treated with anti-amyloid-beta monoclonal antibody therapy within the past 3 months 13. Patient has contraindication for MRI or intrathecal administration of gadobutrol 14. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or study outcomes 15. Patient is ineligible to participate for other reasons in the judgment of the investigator

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Stanford Medical Center Palo Alto California Recruiting
Baptist Health Research Institute Jacksonville Florida Recruiting
The Research Foundation for State University of New York Buffalo New York Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07178210 on ClinicalTrials.gov ↗ ← All trials in the USA