Recruiting

Symani System

Sponsor:

MMI (Medical Microinstruments, Inc.)

Code:

NCT07178210

Conditions

Alzheimer Disease

Lymphatic Obstruction

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Symani Surgical System

Study Details

Brief 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.

Conditions

Alzheimer Disease

Lymphatic Obstruction

Study ID

NCT07178210

Start date

Apr 30, 2026

Status verified date

Aug, 2026

Completion date

Oct 30, 2027

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Alzheimer's Disease

Patient with confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria

Interventions

Symani Surgical System

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Stanford Medical Center

Recruiting

Palo Alto, California, United States, 94305

Contacts

Elizabeth Tadevosyan

etadyan@stanford.edu

Principal Investigator:

Dung Nguyen, MD

Baptist Health Research Institute

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Principal Investigator:

Ricardo Hanel, MD, PhD

The Research Foundation for State University of New York

Recruiting

Buffalo, New York, United States, 14203

Contacts

Ellen Carl

ecarl@ubns.com

Principal Investigator:

Adnan H Siddiqui

More Information

Sponsor

MMI (Medical Microinstruments, Inc.)

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MMI (Medical Microinstruments, Inc.) on 2026-08-24.