Symani robotic system for microsurgical and lymphatic anastomosis
A Multi-Cohort, Prospective Investigation of the Symani® Surgical System: A Novel Approach to the Next Frontier of Microsurgery and Expanding Access to Care in Free Tissue Transfer and Lymphatic Surgery
This trial will try the Symani robot to help surgeons connect tiny blood and lymph vessels during free flap and lymphedema surgeries for adults who need microsurgical anastomosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | MMI (Medical Microinstruments, Inc.) Industry-sponsored |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT06866197 on ClinicalTrials.gov |
What this trial studies
CONNECT is a prospective, multi-cohort study using the Symani surgical system during standard-of-care free tissue transfer and lymphatic surgeries. Patients receive the planned surgical procedure with the device used for the microvascular or lymphatic anastomosis, and outcomes are collected per protocol. The main effectiveness endpoint is intraoperative anastomosis patency and the main safety endpoint is freedom from device-related serious adverse events before discharge, adjudicated by a Clinical Events Committee. Therapeutic lymphatic patients will complete questionnaires and limb volume assessments, while prophylactic patients will undergo limb volume assessments, and all participants are followed at scheduled visits.
Who should consider this trial
Good fit: Adults who need microsurgical anastomosis for free flap transfer or extremity lymphatic surgery, can give informed consent, and can attend required follow-up visits are ideal candidates.
Not a fit: Patients whose lymphedema is fully reversed by decongestive therapy, those not suitable for robotic-assisted microsurgery, or those unable to attend the required procedure site and follow-up visits are unlikely to benefit.
Why it matters
Potential benefit: If successful, the Symani system could improve the precision and durability of microanastomoses, potentially reducing flap failures and improving lymphedema outcomes.
How similar studies have performed: Early feasibility reports and small series of robotic microsurgery, including work with the Symani system, have shown promising technical success but large controlled outcome data are limited.
Eligibility criteria
Show full inclusion / exclusion 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 lymphatic 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 * Maintain complete decongestive therapy (CDT), according to International Society of Lymphology (ISL) guidelines, for a minimum duration of four (4) 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: * The patient has at least one identifiable risk factor for developing lymphedema of the extremities * Patient with 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 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
Where this trial is running
Melbourne, Victoria
- Saint Vincent's Hospital Melbourne — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Clinical Operations
- Email: clinical.ops@mmimicro.com
- Phone: 8336646276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.