A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis

Launched by MMI (MEDICAL MICROINSTRUMENTS, INC.) · Oct 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new surgical tool called the Symani System, which is used to help surgeons connect small blood vessels during surgeries for conditions like lymphedema and tissue transfer. The main goal of the study is to see how safe and effective this system is in making these connections during surgery. Researchers will track how well the surgery goes and any serious problems that might happen related to the device.

To participate, you need to be an adult who has a medical reason for needing this type of surgery. If you're undergoing a treatment for lymphedema, you’ll complete a questionnaire and have some measurements taken of your affected limb. All participants will need to agree to follow-up visits and allow researchers to access their information. It's important to note that this study is not yet recruiting participants, and there are specific criteria that might make you eligible or ineligible based on your health history and medical conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults, according to the local law
• • Patient agrees to participate in the study, return for all required follow-up visits, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure
• • Patient with a clinical indication for a microsurgical anastomosis for a free flap transfer surgery and/or lymphedema surgery
• • Investigator considers candidate acceptable for free flap transfer surgery and/or lymphatic surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System IFU
• Inclusion Criteria for Therapeutic Lymphatic Patients:
• • For lymphedema of the extremities, swelling of lymphedema that is not completely reversed by decongestion therapy modalities. (Not applicable for patients with lymphedema of the head and neck)
• * For lymphedema of the extremities, at least one of the following positive quantitative measurements (not applicable for patients with lymphedema of the head and neck):
• • 1. Volumetry differential between diseased limb and contralateral limb must be at least 10% of the other
• • 2. Bioimpedance (L-Dex) differential, if feasible, between diseased limb and contralateral limb of at least 10 units
• • Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening
• • Willingness to comply with recommended regimen of self-care, with consistent use of compression garments from screening through the entire study duration
• • Patient must be diagnosed with Lymphedema
• • Patient must have a body mass index (BMI) of ≤ 35
• Inclusion Criteria for Prophylactic Lymphatic Patients:
• • In the opinion of the investigator, the patient has at least one identifiable indication for prophylactic lymphatic surgery.
• • Patient must have a body mass index (BMI) of ≤ 35
• Exclusion Criteria:
• • Patients who are not capable and/or unwilling to provide informed consent
• • Clinically significant cardiovascular, digestive, respiratory, endocrine, liver 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 (either venous or arterial)
• • Previously documented history of chronic kidney disease (eGFR ≤ 30)
• • 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 patients ineligible to participate for other reasons in the judgement of the investigator
• Exclusion Criteria for Free Tissue Transfer Patients:
• • Patients with buried flaps
• • Multiple flaps planned for the procedure
• Exclusion Criteria for Therapeutic Lymphatic Patients:
• • 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
• • Current infection in the affected area of lymphedema
• • Current evidence of malignancy
• • Known iodine sensitivity
• • Patient's lymphatic disease is due to lipedema
• • Patients with bilateral lymphedema or lymphedema in multiple anatomical locations
• Exclusion Criteria for Prophylactic Lymphatic Participants:
• • Patients for whom prophylactic surgery on more than one limb is planned
• • Known iodine sensitivity
• • Patients with post-thrombotic syndrome, arterial insufficiency, deep vein thrombosis or any other medical condition that could make them ineligible to participate in the judgment of the investigator
• • Patients diagnosed with lymphedema
• • Patients who have received prior radiation therapy to the affected limb where the investigator believes the amount or extent of radiation could compromise the success of prophylactic lymphatic surgery
• Intraoperative 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 two robotic sutures attempted during the index procedure