The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphatic surgery. The primary endpoints are: * Effectiveness: Clinical Success, defined as intraoperative anastomosis patency. * Safety: Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee. Participants will receive treatment as standard of care and be asked to: * Allow the researchers to access and use their information. * If participants are undergoing a therapeutic lymphatic procedure, they will be asked to complete a questionnaire and undergo lymphedema volume assessments as part of the study. If participants are undergoing a prophylactic lymphatic procedure, they will only be asked to undergo limb volume assessments. * Participants will be asked to comply with the follow-up visits as outlined in the protocol.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
1,000
The Symani Surgical System (Symani) is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.
Clinical Success, defined as intraoperative anastomosis patency.
Clinical Success is defined as intraoperative anastomosis patency. Intraoperative anastomosis patency will be measured for each robotic anastomosis (anastomosis contains at least two robotically placed sutures) per standard of care and will be evaluated prior to closure of the procedure site during the index procedure.
Time frame: The duration of the participants' index procedure, from when they enter the OR to when they leave the OR (procedures typically last under 24 hours).
Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee.
Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee. All device-related serious adverse events will be descriptively summarized.
Time frame: The duration of the participants' index procedure hospitalization (typically lasting under two weeks).
Freedom from a reoperation to revise a robotic anastomosis prior to discharge
Freedom from returning to the operating room for surgical revisions to an anastomosis that was deemed robotic (anastomosis contains at least two robotically placed sutures) in the index procedure. This endpoint will be evaluated at discharge for each participant.
Time frame: The duration of the participants' index procedure hospitalization (typically lasting under two weeks).
Rate of intra-operative approach changes from robotic to manual
An intra-operative approach change is defined as a conversion from a robotic anastomosis approach to a manual anastomosis approach. This endpoint will be evaluated upon completion of the index procedure.
Time frame: The duration of the participants' index procedure, from when they enter the OR to when they leave the OR (procedures typically last under 24 hours).
Technical success
Technical success is defined as freedom from device malfunction resulting in unplanned conventional suturing. Device malfunctions and the associated outcome will be collected. This endpoint will be evaluated upon completion of the index procedure.
Time frame: The duration of the participants' index procedure, from when they enter the OR to when they leave the OR (procedures typically last under 24 hours).
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