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The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during open lymphatic reconstruction in the head and neck.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Head and Neck Lymphedema | Experimental | The patients selected for the CLEAR Study will be adults over 22 years of age with a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with lymphatic reconstruction of the head and neck. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symani Surgical System | Device | Symani® Surgical System is intended to perform surgical techniques during open microsurgical procedures. |
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| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative anastomosis patency prior to closure. | Intraoperative anastomosis patency prior to closure will be measured for each robotic anastomosis using indocyanine green (ICG) fluorescence imaging and will be evaluated prior to closure of the procedure site during the index procedure. | The duration of the participants' index procedure. |
| Freedom from device-related adverse events | All adverse events will be evaluated from the start of the index procedure through 30 days post index procedure. | The duration of the participants' index procedure through 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in flow pathways | Change in flow pathways will be assessed by an ICG lymphangiography | From the pre-operative visit through 6 months post index procedure. |
| Change in MD Anderson Lymphedema Rating Scale for facial lymphedema |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Scale ranges from 0-3, the higher score indicating worse disease state.
| From the pre-operative visit through 6 months post index procedure. |
| Assessment of Lymphedema of the Head and Neck Area (ALOHA) method for lymphedema measurement | From the pre-operative visit through 6 months post index procedure. |
| Change in Head and Neck Lymphedema and Fibrosis Symptom Inventory | It contains 33 items (symptoms) which are answered Yes or No. If the response is Yes to any given item, the patient is asked to rate the intensity of the symptom on a 5-point Likert scale. Each symptom then receives a score ranging from 0 (does not experience the symptom) to 5 (experiences the symptom with severe intensity). | From the pre-operative visit through 6 months post index procedure. |
| Change in internal lymphedema | Assessed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) Examination | From the pre-operative visit through 6 months post index procedure. |
| Technical Success | as freedom from any device malfunction resulting in unplanned conventional (manual) suturing | The duration of the participants' index procedure. |
| All-cause readmission rates | The duration of the participants' index procedure through 30 days post index proceudre. |
| Procedure-related adverse events (AEs) rate | The duration of the participants' index procedure through 30 days post index proceudre. |
| Serious adverse events (AEs) rate | The duration of the participants' index procedure through 30 days post index proceudre. |
| Anastomosis-specific reoperation rate | The duration of the participants' index procedure through 30 days post index proceudre. |