Clinical trial Recruiting at 1 site Interventional Ages 18 to 100

Symani robotic system for microsurgical and lymphatic anastomosis

Official title: 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

Run by MMI (Medical Microinstruments, Inc.) · NCT06866197 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 100 Years
SexAll
Enrollment180 (estimated)
SponsorMMI (Medical Microinstruments, Inc.)
Industry-sponsored
Locations1 site (Melbourne, Victoria)
StatusRecruiting
StartedJanuary 20, 2026
Main results expectedJanuary 20, 2028
Study endsJanuary 20, 2029
Registry record updatedApril 2, 2026
Trial IDNCT06866197 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Saint Vincent's Hospital Melbourne
    Melbourne, Victoria, Australia
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.