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.
Adults, according to the local law
Patient agrees to participate in the study, return for all required follow-up visits, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure
Patient with a clinical indication for a microsurgical anastomosis for a free flap transfer surgery and/or lymphedema surgery
Investigator considers candidate acceptable for free flap transfer surgery and/or lymphatic surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System IFU
Patients who are not capable and/or unwilling to provide informed consent
Clinically significant cardiovascular, digestive, respiratory, endocrine, liver 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
Patients with implanted pacemaker
Single group
Symani Surgical System
DeviceThe 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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
