The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery.
The primary endpoints are:
* Effectiveness- Rate of intraoperative anastomosis patency at first attempt. * Safety- Freedom from device-related adverse events.
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 lymphedema procedure, they will be asked to undergo a questionnaire as part of the study. * Participants will be asked to comply with the follow-up visits and complete all study procedures/questionnaires as outlined in the protocol.
At least 22 years of age
Patient agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure
Patient has a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with open free-flap surgery of the breast or extremities and/or lymphovenous anastomosis surgery of the extremities
Investigator deems the candidate acceptable for free flap transfer surgery and/or lymphovenous anastomosis surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU)
Patients who are incapable and/or unwilling to provide informed consent
Active systemic infection under treatment with intravenous antibiotics
Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators discretion
Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
The patients selected for the PRECISE Study will be adults with a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with open free flap surgery of the breast or extremities and/or lymphovenous anastomosis surgery of the extremities.
Cohort
Prospective
Symani Surgical System
DeviceThe Symani Surgical System (Symani) is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.
Freedom from device-related adverse events from the start of the index procedure through 30-days post index procedure as adjudicated by a Clinical Events Committee
All adverse events will be evaluated from the start of the index procedure through 30-days post index procedure. Adverse events will be reviewed by a Clinical Events Committee (CEC) to determine probable or causal relationships with the device. All device-related serious adverse events will be summarized descriptively.
Intraoperative anastomosis patency at first attempt.
Intraoperative anastomosis patency will be measured for each robotic anastomosis per standard of care and will be evaluated after the first attempt of the anastomosis during the index procedure.
Intraoperative anastomosis patency prior to closure.
Intraoperative anastomosis patency prior to closure will be measured for each robotic anastomosis per standard of care and will be evaluated prior to closure of the procedure site during the index procedure.
Anastomosis suturing time (including robotic time and manual time).
Anastomosis suturing time of the index procedure will be collected for each participant and summarized. Robotic anastomosis time and manual anastomosis time will be recorded for each anastomosis. For each anastomosis within an operation, the total suture time (robotic plus manual) will be derived as total robotic anastomosis time plus total manual anastomosis time.
Number of robotic and manual stitches per anastomosis.
The number of robotic stitches placed and the number of manual stitches placed per anastomosis in the index procedure will be collected for each anastomosis and summarized. For each anastomosis within an operation, the total stitches placed (robotic plus manual) will be derived as total robotic stitches placed plus total manual stitches.
Procedure time.
Procedure time of the index procedure will be collected for each participant and summarized. The incision start time and closure end time will be recorded. The procedural time will be derived from incision time subtracted from closure time.
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