Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorMMI (Medical Microinstruments, Inc.)
About this trial
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 criteria
Qualifiers
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)
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.
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
Trial design
Treatments tested in this trial
- Symani Surgical System
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov