A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgi… (NCT06725030) | Clinical Trial Compass
RecruitingNot Applicable
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
United States455 participantsStarted 2025-09-22
Plain-language summary
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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
. Swelling of one limb that is not completely reversed by elevation or compression
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: From participants index procedure through 30-days post index procedure.
2
Intraoperative anastomosis patency at first attempt.
Timeframe: The duration of the participants index procedure.
. Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
. At least one of the following positive quantitative measurements:
. Volumetry differential between affected limb and contralateral limb must be at least 10% of the other
Exclusion criteria
. 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
. Patients with implanted pacemaker
. Planned vein graft
. Currently receiving chemotherapy or radiation therapy