Actively Recruiting
CONNECT: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System
Led by MMI (Medical Microinstruments, Inc.) · Updated on 2026-04-02
180
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphatic surgery. The primary endpoints are: Effectiveness: Clinical Success, defined as intraoperative anastomosis patency. Safety: Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee. 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 therapeutic lymphatic procedure, they will be asked to complete a questionnaire and undergo lymphedema volume assessments as part of the study. If participants are undergoing a prophylactic lymphatic procedure, they will only be asked to undergo limb volume assessments. Participants will be asked to comply with the follow-up visits as outlined in the protocol.
CONDITIONS
Official 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 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
- For lymphedema of the extremities, swelling not completely reversed by decongestion therapy (not applicable for head and neck lymphedema)
- For lymphedema of the extremities, at least one positive quantitative measurement: volumetry differential of at least 10% between limbs or bioimpedance differential of at least 10 units (not applicable for head and neck lymphedema)
- Maintain complete decongestive therapy for at least four weeks prior to screening
- Willingness to comply with recommended self-care and consistent use of compression garments throughout the study
- Patient diagnosed with lymphedema
- Patient has a body mass index (BMI) of 35 or less
- For prophylactic lymphatic patients, at least one identifiable risk factor for developing lymphedema of the extremities
- Patient has a body mass index (BMI) of 35 or less
You will not qualify if you...
- Patients unable or unwilling to provide informed consent
- Clinically significant cardiovascular, digestive, respiratory, endocrine, liver, or central nervous system disorders; previous mental disorders; or other conditions affecting data collection or protocol compliance
- History of significant bleeding, coagulopathy, or Von Willebrand's disease
- Patients with implanted pacemaker
- Planned vein graft (venous or arterial)
- History of chronic kidney disease with eGFR ≤ 30
- Currently enrolled in other investigational clinical studies impacting safety or outcomes
- Vulnerable populations such as pregnant women or others deemed ineligible by investigator
- For free tissue transfer patients: buried flaps or multiple flaps planned
- For therapeutic lymphatic patients: venous edema, acute limb edema conditions, current infection in affected area, evidence of malignancy, iodine sensitivity, lipedema-related lymphatic disease, bilateral or multiple location lymphedema
- For prophylactic lymphatic patients: prophylactic surgery planned on more than one limb, iodine sensitivity, post-thrombotic syndrome, arterial insufficiency, deep vein thrombosis, or other disqualifying conditions
- Intraoperative exclusions: conditions making participation unsafe or fewer than two robotic sutures attempted during surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Saint Vincent's Hospital Melbourne
Melbourne, Victoria, Australia, 3065
Actively Recruiting
Research Team
C
Clinical Operations
CONTACT
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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