Expanding access to microsurgery with the Symani robotic system

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

This study will test the Symani robotic system to help surgeons sew very small blood vessels during free-flap and lymphovenous surgeries in adults.

Quick facts

• Study type: Observational
• Enrollment: 455 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: MMI (Medical Microinstruments, Inc.) (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 4 sites (Beverly Hills, California and 3 other locations)
• Trial ID: NCT06725030 on ClinicalTrials.gov

What this trial studies

This is a post-market, observational, real-world registry of the Symani Surgical System used during open free tissue transfer and lymphovenous anastomosis procedures. Participants receive standard surgical care while surgeons use the device and investigators record intraoperative outcomes, device-related adverse events, and follow-up data. The primary effectiveness endpoint is the rate of intraoperative anastomosis patency at first attempt and the primary safety endpoint is freedom from device-related adverse events. Adults with clinical indication for microsurgical anastomosis of vessels between 0.1 and 2.5 mm who consent and can complete follow-up are eligible.

Who should consider this trial

Good fit: Adults aged 22 or older undergoing free tissue transfer for breast or extremity reconstruction or lymphovenous anastomosis with vessel sizes between 0.1 and 2.5 mm who can consent and attend follow-ups are ideal candidates.

Not a fit: Patients under 22, those with vessels outside the 0.1–2.5 mm range, or those not suitable for robotic-assisted microsurgery are unlikely to benefit from this device-based approach.

Why it matters

Potential benefit: If successful, the Symani system could increase first-attempt vessel patency and reduce technical strain on surgeons, potentially improving flap success and patient recovery.

How similar studies have performed: Small case series and early clinical reports have shown feasibility and acceptable safety for robot-assisted microsurgery, but large comparative trials remain limited.

Eligibility criteria

Pre Operative Inclusion Criteria:

1. At least 22 years of age
2. 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
3. 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
4. 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)

Cohort Specific Pre- Operative Inclusion Criteria:

Free Tissue Transfer Surgery: N/A

Lymphovenous Anastomosis Surgery

1. Swelling of one limb that is not completely reversed by elevation or compression
2. Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
3. At least one of the following positive quantitative measurements:

   1. Volumetry differential between affected limb and contralateral limb must be at least 10% of the other
   2. Bioimpedance (L-Dex) differential, if feasible, between affected limb and contralateral limb of at least 10 units
4. Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines, for at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen
5. Willingness to comply with recommended regimen of self-care, with consistent use of appropriately sized compression garments from screening through the entire study duration (through the 3-month follow-up visit).

Pre-Operative Exclusion Criteria:

1. Patients who are incapable and/or unwilling to provide informed consent
2. Active systemic infection under treatment with intravenous antibiotics
3. 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
4. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
5. Patients with implanted pacemaker
6. Planned vein graft
7. Currently receiving chemotherapy or radiation therapy
8. History of chronic kidney disease
9. History of chronic liver disease
10. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes
11. Patients belonging to vulnerable populations, such as pregnant women, or ineligible to participate for other reasons in the judgement of the investigator

Cohort Specific Pre-Operative Exclusion Criteria:

Free Tissue Transplant Surgery:

1. Patients with buried flaps
2. Multiple flaps planned for the procedure

Lymphovenous Anastomosis Surgery:

1. Patients \> 75 years of age
2. Patients with prior lymphatic reconstruction surgery
3. Patients with venous edema (arising from increased capillary filtration)
4. Patients with other medical conditions that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure
5. Patients with other medical conditions that could result in symptoms which overlap symptoms of lymphedema
6. Current infection in the affected limb
7. Patients who experience more than one episode of cellulitis in a six month period over the past two years
8. Current evidence or a history of malignancy within the past 6 months (if the participant has undergone cancer treatment, this must have been completed \> 6 months prior to enrollment)
9. Known iodine sensitivity
10. Patient's lymphatic disease is due to lipedema
11. Patients with bilateral lymphedema or lymphedema in multiple anatomical locations

Intra Operative Exclusion Criteria:

1. Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would make participating in this study not in the patient's best interest
2. The patient does not have at least one robotic stitch attempted during the index procedure

Where this trial is running

Beverly Hills, California and 3 other locations

• Cedars Sinai Medical Center — Beverly Hills, California, United States (Recruiting)
• Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
• Tampa General Hospital — Tampa, Florida, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Bohdan Pomahac, MD — Yale New Haven Medical Center
• Study coordinator: Clinical Operations

Conditions Open Surgery; Lymphedema; Free Tissue Transfer; Microsurgery; Anastomosis, Surgical