Evaluating the Symani Surgical System for Microsurgery
This study is looking at the Symani Surgical System, a device designed to help surgeons perform very delicate operations called microsurgery. Specifically, it's being used for procedures like free tissue transfer (moving tissue from one part of the body to another) and lymphovenous anastomosis (connecting lymph vessels to veins, often for lymphedema treatment). Researchers want to see how safe and effective the Symani System is. They will measure how often the connections made during surgery (anastomosis) are successful on the first try, and if there are any problems related to the device within 30 days after surgery. You can join if you are at least 22 years old and agree to follow the study's instructions and attend follow-up visits. This is an observational study, meaning you will receive standard care, and researchers will collect information about your experience.
- Study design
- This is an observational study planning to enroll 455 participants. It is not specified if it is randomized or blinded.
- What's involved
- You will receive standard care and be asked to allow researchers to access your information, complete questionnaires if undergoing a lymphedema procedure, and comply with follow-up visits and study procedures.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for device-related adverse events from the start of your procedure through 30 days afterward.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
At a glance
Conditions
Where it's being run
6 sites across 5 statesStudy leadership
- Bohdan Pomahac, MD · PRINCIPAL_INVESTIGATOR · Yale New Haven Medical Center
Who to contact
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What this trial measures
- 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 CommitteeFrom participants index procedure through 30-days post index procedure.
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.The duration of the participants index procedure.
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.