Actively Recruiting
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Led by MMI (Medical Microinstruments, Inc.) · Updated on 2026-03-05
455
Participants Needed
4
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
- For lymphovenous anastomosis surgery: swelling of one limb that is not completely reversed by elevation or compression
- 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 of at least 10% or bioimpedance (L-Dex) differential of at least 10 units
- Completion of a full course of complete decongestive therapy (CDT) for at least 12 weeks prior to screening, including use of compression garments without change in regimen
- Willingness to comply with recommended self-care and consistent use of compression garments from screening through the entire study duration
You will not qualify if you...
- Patients who are incapable and/or unwilling to provide informed consent
- Active systemic infection under treatment with intravenous antibiotics
- Significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, or other conditions affecting data collection or protocol compliance as judged by the investigator
- Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
- Presence of implanted pacemaker
- Planned vein graft
- Currently receiving chemotherapy or radiation therapy
- History of chronic kidney disease
- History of chronic liver disease
- Currently enrolled in other investigational clinical studies that may impact safety or outcomes
- Patients belonging to vulnerable populations, including pregnant women, or deemed ineligible by the investigator
- For free tissue transfer surgery: patients with buried flaps or multiple flaps planned
- For lymphovenous anastomosis surgery: patients over 75 years old
- Prior lymphatic reconstruction surgery
- Venous edema from increased capillary filtration
- Other medical conditions causing acute limb edema or symptoms overlapping lymphedema
- Current infection in the affected limb
- More than one episode of cellulitis in six months over the past two years
- Evidence or history of malignancy within the past 6 months (cancer treatment must be completed over 6 months before enrollment)
- Known iodine sensitivity
- Lymphatic disease due to lipedema
- Bilateral lymphedema or lymphedema in multiple locations
- Intraoperative conditions making participation unsafe
- No robotic stitch attempted during the index procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Cedars Sinai Medical Center
Beverly Hills, California, United States, 90048
Actively Recruiting
2
Yale New Haven Hospital
New Haven, Connecticut, United States, 06511
Actively Recruiting
3
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
C
Clinical Operations
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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