NCT06725030 · MMI (Medical Microinstruments, Inc.)
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
(PRECISE)
What this study 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 side effects.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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) Cohort Specific Pre- Operative Inclusion Criteria: Free Tissue Transfer Surgery: N/A 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 must be at least 10% of the other
- Bioimpedance (L-Dex) differential, if feasible, between affected limb and contralateral limb of at least 10 units
- 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
- 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
- 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
- History of chronic kidney disease
- History of chronic liver disease
- Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes
- 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:
- Patients with buried flaps
- Multiple flaps planned for the procedure Lymphovenous Anastomosis Surgery:
- Patients \> 75 years of age
- Patients with prior lymphatic reconstruction surgery
- Patients with venous edema (arising from increased capillary filtration)
- Patients with other medical conditions that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure
- Patients with other medical conditions that could result in symptoms which overlap symptoms of lymphedema
- Current infection in the affected limb
- Patients who experience more than one episode of cellulitis in a six month period over the past two years
- 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)
- Known iodine sensitivity
- Patient's lymphatic disease is due to lipedema
- Patients with bilateral lymphedema or lymphedema in multiple anatomical locations Intra Operative Exclusion Criteria:
- 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
- The patient does not have at least one robotic stitch attempted during the index procedure
Where
- Beverly Hills, California
- New Haven, Connecticut
- Tampa, Florida
- Buffalo, New York
- New York, New York
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations