Actively Recruiting
A Multi-Cohort, Prospective Investigation of the Symani Surgical System: A Novel Approach to Microsurgery and Expanding Access in Free Tissue Transfer and Lymphatic Surgery
Led by MMI (Medical Microinstruments, Inc.) · Updated on 2026-04-02
180
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Symani Surgical System to assess its safety and effectiveness for microsurgical anastomosis during free tissue transfer and lymphatic surgeries. The study focuses on clinical success defined by the patency of the anastomosis during surgery and the absence of serious device-related adverse events before discharge. This research aims to support the next frontier in microsurgery and improve access to care. Participants will undergo surgery using the Symani Surgical System, a device designed for open microsurgery with articulated and interchangeable instruments. The study includes multiple cohorts such as free tissue transfer, therapeutic lymphatic surgery, and prophylactic lymphatic surgery patients. During the study, participants will receive standard surgical care assisted by the device and complete specific assessments depending on their surgery type. Participants will be asked to allow researchers access to their medical information and to complete questionnaires and limb volume assessments if undergoing therapeutic lymphatic procedures. Those in prophylactic lymphatic surgery will have limb volume assessments. Follow-up visits will be scheduled as per the study protocol to monitor outcomes such as anastomosis patency, device safety, reoperation rates, and any changes from robotic to manual procedures. The duration of hospital stays and surgeries will be tracked, typically lasting under two weeks and 24 hours respectively.
CONDITIONS
Brief Title
CONNECT: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults according to local law
- Patient agrees to participate, return for follow-up visits, and provides written informed consent
- Patient has clinical indication for microsurgical anastomosis for free flap transfer and/or lymphatic surgery
- Investigator considers patient suitable for robotic assisted microsurgical anastomosis using the Symani System
- For therapeutic lymphatic patients: lymphedema with swelling not fully reversed by decongestion therapy
- For therapeutic lymphatic patients: at least one positive measurement such as 10% volumetry difference or 10 units bioimpedance difference
- Complete decongestive therapy for at least 4 weeks prior to screening
- Willing to comply with self-care and consistent compression garment use
- Diagnosed with lymphedema
- Body mass index (BMI) of 35 or less
- For prophylactic lymphatic patients: at least one risk factor for developing lymphedema
- Body mass index (BMI) of 35 or less
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Significant cardiovascular, digestive, respiratory, endocrine, liver, central nervous system, or mental disorders affecting study compliance
- History of significant bleeding, coagulopathy, or Von Willebrand's disease
- Presence of implanted pacemaker
- Planned venous or arterial vein graft
- Chronic kidney disease with eGFR of 30 or less
- Enrollment in other investigational studies that may affect safety or outcomes
- Vulnerable populations including pregnant women or those judged ineligible by investigator
- For free tissue transfer patients: buried flaps or multiple planned flaps
- For therapeutic lymphatic patients: venous edema, acute limb edema from other causes, current infection, active malignancy, iodine sensitivity, lipedema, bilateral or multiple location lymphedema
- For prophylactic lymphatic patients: planned surgery on more than one limb, iodine sensitivity, post-thrombotic syndrome, arterial insufficiency, deep vein thrombosis, or other conditions making participation unsuitable
- Intraoperative findings making participation unsafe or absence of at least two robotic suture attempts during surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours (duration of the index surgical procedure)
Participants undergo microsurgical procedures using the Symani Surgical System for free tissue transfer or lymphatic surgery.
1 surgical visit (in-person)
Duration - Up to 2 weeks (duration of the index hospitalization)
Participants receive immediate post-operative care during their hospitalization after surgery.
Hospital stay with daily assessments
Duration - Duration not specified
Participants are followed to assess surgical success and monitor for any device-related adverse events or complications.
Follow-up visits as scheduled by the investigator
Trial Site Locations
Total: 1 location
1
Saint Vincent's Hospital Melbourne
Melbourne, Victoria, Australia, 3065
Actively Recruiting
Research Team
C
Clinical Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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