Actively Recruiting
PRECISE: 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
13 weeks
Total Duration
On this page
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 surgery and lymphovenous anastomosis surgery. This observational study aims to assess the device's performance in real-world settings, focusing on the rate of successful vessel connection in the first surgical attempt and the absence of device-related adverse events. Participants will receive standard surgical care using the Symani Surgical System, which offers articulated, interchangeable instruments designed for open microsurgery procedures. The study includes patients undergoing free tissue transfer of the breast or extremities and those having lymphovenous anastomosis surgery for lymphedema. During the trial, participants will have their surgical procedures assessed and may complete questionnaires if undergoing lymphedema procedures. Throughout the study, researchers will monitor the safety and effectiveness of the device by evaluating intraoperative vessel patency and tracking any adverse events up to 30 days after surgery. Participants will be asked to allow access to their medical information, attend follow-up visits, and complete all study procedures and questionnaires. The total participation covers the surgery period and a 30-day post-surgery follow-up to ensure comprehensive safety and outcome monitoring.
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
Eligibility Criteria
You may qualify if you...
- At least 22 years of age
- Patient agrees to participate, return for all follow-ups, complete all study procedures, and has provided informed consent
- Clinical indication for microsurgical anastomosis of vessels between 0.1 and 2.5 mm with free-flap surgery of the breast or extremities and/or lymphovenous anastomosis surgery of the extremities
- Investigator deems patient suitable for free flap transfer and/or lymphovenous anastomosis surgery with robotic assistance per Symani System's Instructions for Use
- For lymphovenous anastomosis surgery: swelling in one limb not fully relieved by elevation or compression
- Stage I-II lymphedema at screening based on ISL staging
- Positive quantitative measurement: at least 10% volume difference between limbs or L-Dex bioimpedance difference of at least 10 units
- Completed at least 12 weeks of complete decongestive therapy including compression garments without regimen change
- Willingness to comply with self-care and consistent compression garment use through the 3-month follow-up
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 collection or compliance
- Known significant bleeding disorders 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 clinical studies impacting safety or outcomes
- Vulnerable populations such as pregnant women or deemed ineligible by investigator
- For free tissue transfer: buried flaps or multiple flaps planned
- For lymphovenous anastomosis: age over 75, prior lymphatic reconstruction, venous edema, acute limb edema conditions, symptom overlap conditions, current limb infection, frequent cellulitis episodes, recent malignancy within 6 months, iodine sensitivity, lipedema-related lymphatic disease, bilateral or multi-location lymphedema
- Intraoperative exclusion: any condition making participation unsafe or if no robotic stitch attempted during procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of the participant's index surgical procedure
Participants undergo microsurgical procedures using the Symani Surgical System for free tissue transfer or lymphovenous anastomosis surgery.
1 surgical procedure visit (in-person)
Duration - 30 days post index procedure
Participants are monitored for device-related safety and clinical outcomes following their surgery.
Follow-up visits up to 30 days after surgery
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
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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