Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - EU

ConditionAlzheimer's
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorMMI (Medical Microinstruments, Inc.)

About this trial

The objective of this study is to evaluate the safety and feasibility of the Symani System and microsurgical techniques in the deep Cervical Lymph Node (dCLN) region in patients with confirmed Alzheimer's disease.

Eligibility criteria

Qualifiers

Patient aged 50 to < 80 years

Patient has confirmed highly probable or probable Alzheimer's disease according to the International Working Group (IWG) Patient and has a positive core 1 Alzheimer biomarker according to the Alzheimer's Association (AA) criteria

Patient has an MMSE score≥ 18

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)

Disqualifiers

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.

History of head and neck radiation exposure

Patient with severe kidney disease (GFR <30 mL/min/1.73m2)

Trial design

Treatments tested in this trial

  • Symani Surgical System

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

This trial has no locations