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
This trial does not accept healthy volunteersQualifiers
50 to 80 years of age
Patients who are of childbearing potential must agree to use a medically acceptable form of contraception for the duration of the study
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
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
Design model
Single group
Treatments tested in this trial
Symani Surgical System
DeviceUse of Symani Surgical System for performing microsurgical techniques in the deep cervical lymph nodes.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Alzheimer's DiseaseExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
The duration of the participants' index procedure through 30-days post index procedure.Secondary outcomes
1
Rate of Serious Adverse Events (SAEs) at 6 months
All intraoperative and postoperative SAEs, regardless of device relatedness, will be captured from the start of the index procedure through 6 months days post-index procedure for each participant. The freedom from SAE rate will be reported at 6 months post-index procedure for all evaluable participants.
Time frame
The duration of the participants' index procedure through 6-months post index procedure.2
Rate of Adverse Events (AEs) at 30 days
All intraoperative and postoperative AEs, regardless of seriousness or device relatedness, will be captured from the start of the index procedure through 3 months days post-index procedure for each participant. The freedom from AE rate will be reported at 3 months post-index procedure for all evaluable participants.
Time frame
The duration of the participants' index procedure through 30-days post index procedure.3
Anastomosis-Specific Reoperation Rate at 30 Days
An anastomosis-specific reoperation is defined as a reoperation to revise a robotic anastomosis, which may consist of the addition of stitches, the removal of stitches, or any other form of reoperation directly to robotic anastomoses performed in the index procedure. All anastomosis-specific reoperations will be captured from the end of the index procedure through 30 days post-index procedure for each participant. All anastomosis-specific reoperations will be reviewed by a DSMB Charter. The anastomosis-specific reoperation rate will be reported at 30 days post-index procedure for all evaluable participants.
Time frame
The duration of the participants' index procedure through 30-days post index procedure.4
Change in Amyloid PET Centiloid Value at 6 Months
The centiloid (CL) value of an amyloid positron emission tomography (PET) imaging test will be recorded at the patient's pre-procedure visit and at the 6-month follow-up visit.
Time frame
The duration of the participants' pre-procedure visit through 6-months post index procedure.Sponsors and contacts
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Source ClinicalTrials.gov