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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Symani® Surgical System is intended to perform surgical techniques during open microsurgical procedures.
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.
Time frame: 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.
Time frame: The duration of the participants' index procedure through 30 days.
Change in flow pathways
Change in flow pathways will be assessed by an ICG lymphangiography
Time frame: From the pre-operative visit through 6 months post index procedure.
Change in MD Anderson Lymphedema Rating Scale for facial lymphedema
Scale ranges from 0-3, the higher score indicating worse disease state.
Time frame: 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
Time frame: 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).
Time frame: From the pre-operative visit through 6 months post index procedure.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in internal lymphedema
Assessed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) Examination
Time frame: 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
Time frame: The duration of the participants' index procedure.
All-cause readmission rates
Time frame: The duration of the participants' index procedure through 30 days post index proceudre.
Procedure-related adverse events (AEs) rate
Time frame: The duration of the participants' index procedure through 30 days post index proceudre.
Serious adverse events (AEs) rate
Time frame: The duration of the participants' index procedure through 30 days post index proceudre.
Anastomosis-specific reoperation rate
Time frame: The duration of the participants' index procedure through 30 days post index proceudre.