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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.
A prospective, multi-center, early feasibility study, designed to evaluate the Symani System's safety and feasibility for performing microsurgical techniques in the dCLN region to improve clearance of neurotoxins, such as amyloid-beta and phosphorylated tau, in patients with confirmed mild to moderate Alzheimer's disease and lymphatic abnormalities in the dCLN region.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symani Surgical System | Device | Use of Symani Surgical System for performing microsurgical techniques in the deep cervical lymph nodes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The duration of the participants' index procedure through 6-months post index procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Contact | 8336646276 | 5 | clinical.ops@mmimicro.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Medical Center | Recruiting | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. | The duration of the participants' index procedure through 30-days post index procedure. |
| 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. | The duration of the participants' index procedure through 30-days post index procedure. |
| 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. | 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 | Blood panel testing for amyloidβ-42 and 40, ptau-217, neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) will be taken at the patient's pre-procedure visit and at the 6-month follow-up visit. | The duration of the participants' pre-procedure visit through 6-months post index procedure. |
| Anastomosis Patency Prior to Closure | Intraoperative patency of the anastomosis should be assessed prior to closure per site standard of care. This information will be captured for each robotic anastomosis performed during the procedure. | The duration of the participants' index procedure. |
| Intraoperative Conversion to Manual Approach | The rate of conversion to manual approach will be measured during the index procedure for each participant. This information will be captured for each robotic anastomosis performed during the procedure. | The duration of the participants' index procedure. |
| Baptist Health Research Institute | Recruiting | Jacksonville | Florida | 32207 | United States |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |