Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

NCT07178210 | Recruiting DMC FDA Device

• 1 other identifier: CDC-00157
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Device-related serious adverse events at 30-days

  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.

  The duration of the participants' index procedure through 30-days post index procedure.

Secondary Outcomes (7)

• 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.

Study Arms (1)

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

Device: Symani Surgical System

Interventions

Symani Surgical System DEVICE

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

Alzheimer's Disease

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MMI (Medical Microinstruments, Inc.): lead

Study Sites (2)

Stanford Medical Center

Palo Alto, California, 94305, United States

RECRUITING

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Clinical Operations

CONTACT

8336646276; clinical.ops@mmimicro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 17, 2025
• Study Start: March 31, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (2)