Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - A Global, Prospective, Early Feasibility Study in Alzheimer's Patients

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 15 participants

Interventions

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

Primary Outcomes

• Device-related serious adverse events at 30-days (The duration of the participants' index procedure through 30-days post index procedure.)

Secondary Outcomes

• 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.)

Trial Locations

• Baptist Health Research Institute, Jacksonville, Florida, United States

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