What is the Symani Surgical System studying for microsurgical anastomosis?

The Symani Surgical System is being studied to assess its safety and effectiveness during microsurgical anastomosis in free tissue transfer and lymphovenous anastomosis surgeries. Researchers want to understand how well the device maintains vessel connection at the first attempt and whether it causes any device-related problems. The study is sponsored by Medical Microinstruments, Inc.

Who may be eligible for this microsurgical anastomosis clinical trial?

Adults aged 22 years or older with a clinical indication for microsurgical anastomosis of small vessels during free tissue transfer or lymphovenous anastomosis surgery may be eligible. Participants must be willing to complete follow-up visits and study procedures. Certain medical conditions and treatments may exclude participants. Please review eligibility criteria for more details.

Is there any cost to participate in this microsurgical anastomosis clinical trial?

Study-related care, including the use of the Symani Surgical System and all trial visits, is provided at no cost. However, personal travel or other expenses related to participation may vary and are not guaranteed to be covered.

Actively Recruiting

Age: 22Years +

All Genders

ID06725030

Study Evaluating Safety and Effectiveness of the Symani Surgical System in Microsurgical Anastomosis for Free Tissue Transfer and Lymphovenous Anastomosis Surgeries

Led by MMI (Medical Microinstruments, Inc.) · Updated on 2026-07-13

455

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer and lymphovenous anastomosis surgeries. The study focuses on how well the device maintains vessel connection at the first attempt and monitors any device-related adverse events. Participants include adults with clinical indications for these specific microsurgical procedures. The Symani Surgical System, designed for open microsurgery with articulated and interchangeable instruments, is used during surgeries involving vessels between 0.1 and 2.5 mm in diameter. Participants undergo treatment as part of standard care and may be in either free tissue transfer surgery or lymphovenous anastomosis surgery groups. Those in the lymphovenous anastomosis group complete questionnaires and follow prescribed self-care and compression garment use over the study. Participants provide consent for researchers to access their medical information and agree to attend follow-up visits, completing all study procedures and questionnaires. Researchers measure outcomes including device-related adverse events up to 30 days post-procedure and intraoperative vessel patency at first attempt and prior to closure. Additional assessments include procedure times, suturing details, and technical success. The study runs from 2025 to 2027, with ongoing monitoring during the procedure and follow-up visits.

CONDITIONS

Brief Title

A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons

Who Can Participate

Age: 22Years +

All Genders

Eligibility Criteria

You may qualify if you...

At least 22 years of age
Patient agrees to participate, attend all follow-up visits, complete study procedures, and has provided written informed consent
Clinical indication for microsurgical anastomosis of vessels between 0.1 and 2.5 mm during free-flap surgery of the breast or extremities and/or lymphovenous anastomosis surgery of the extremities
Investigator deems the patient suitable for surgery with robotic-assisted microsurgical anastomosis per Symani System's instructions
For lymphovenous anastomosis surgery: swelling of one limb not reversed by elevation or compression
Stage I-II lymphedema at screening based on ISL staging
Positive quantitative measurements including at least 10% limb volume difference or 10 unit bioimpedance differential
Completed at least 12 weeks of complete decongestive therapy including compression garments
Willing to comply with self-care and consistent compression garment use during the study

You will not qualify if you...

Unable or unwilling to provide informed consent
Active systemic infection treated with intravenous antibiotics
Significant cardiovascular, digestive, respiratory, endocrine, central nervous system, or mental disorders affecting data or compliance
History of significant bleeding, coagulopathy, or Von Willebrand's disease
Implanted pacemaker
Planned vein graft
Currently receiving chemotherapy or radiation therapy
History of chronic kidney or liver disease
Enrolled in other investigational studies impacting safety or outcomes
Vulnerable populations such as pregnant women
For free tissue transfer: buried flaps or multiple planned flaps
For lymphovenous anastomosis: age over 75, prior lymphatic reconstruction, venous edema, acute limb edema conditions, more than one episode of cellulitis in 6 months over past 2 years, recent malignancy within 6 months, iodine sensitivity, lipedema-related lymphatic disease, bilateral or multiple location lymphedema
Current infection in affected limb
Intraoperative findings making participation unsafe
No robotic stitch attempted during the procedure

Research Team

Clinical Operations

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