An interventional study of Symani Surgical System in Microsurgery, Lymphedema and Free Tissue Transfer, sponsored by MMI (Medical Microinstruments, Inc.). Recruiting at 1 site in Australia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by MMI (Medical Microinstruments, Inc.) · Not applicable, Interventional, and Other
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.
529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.
This study's planned enrollment of 180 is above the median of 50 across 369 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →MMI (Medical Microinstruments, Inc.) is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria for Therapeutic Lymphatic Patients:
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):
Inclusion Criteria for Prophylactic Lymphatic Patients:
Exclusion Criteria:
Exclusion Criteria for Free Tissue Transfer Patients:
Exclusion Criteria for Therapeutic Lymphatic Patients:
Exclusion Criteria for Prophylactic Lymphatic Participants:
Intraoperative Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Symani Surgical System
The Symani Surgical System (Symani) is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.
Clinical Success, defined as intraoperative anastomosis patency.
Clinical Success is defined as intraoperative anastomosis patency. Intraoperative anastomosis patency will be measured for each robotic anastomosis per standard of care and will be evaluated prior to closure of the procedure site during the index procedure.
Time frame: The duration of the participants' index procedure, from when they enter the OR to when they leave the OR (procedures typically last under 24 hours)
Freedom from device-related serious adverse events prior to discharge from the index hospitalization
Freedom from device-related serious adverse events prior to discharge from the index hospitalization. All device-related serious adverse events will be descriptively summarized.
Time frame: The duration of the participants' index procedure hospitalization (typically lasting under two weeks)
Freedom from a reoperation to revise a robotic anastomosis prior to discharge
Freedom from returning to the operating room for surgical revisions to an anastomosis that was deemed robotic in the index procedure. This endpoint will be evaluated at discharge for each participant.
Time frame: The duration of the participants' index procedure hospitalization (typically lasting under two weeks)
Rate of intra-operative approach changes from robotic to manual
An intra-operative approach change is defined as a conversion from a robotic anastomosis approach to a manual anastomosis approach. This endpoint will be evaluated upon completion of the index procedure.
Time frame: The duration of the participants' index procedure, from when they enter the OR to when they leave the OR (procedures typically last under 24 hours).
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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MMI (Medical Microinstruments, Inc.)