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

Launched by MMI (MEDICAL MICROINSTRUMENTS, INC.) · Dec 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new surgical system called the Symani® Surgical System to see how safe and effective it is for certain types of surgeries, specifically those involving small blood vessel connections during procedures like free tissue transfer and lymphedema treatment. The study aims to find out if surgeons can successfully connect vessels using this system the first time they try (called "anastomosis patency") and to ensure that the device doesn’t cause any harmful side effects.

To participate in this trial, you need to be at least 22 years old and have a medical need for microsurgery involving small blood vessels. If you're having a lymphedema procedure, you will also need to complete a questionnaire. Participants will receive standard care for their condition, but they must agree to follow the study's requirements, which include attending follow-up visits and answering questions about their health. It's important to note that not everyone can join; for instance, individuals with certain medical conditions or those over 75 years old may be excluded. Overall, this trial is designed to help improve surgical options for patients needing advanced care.

Gender

ALL

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