CONNECT: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorMMI (Medical Microinstruments, Inc.)
About this trial
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.
Eligibility criteria
Qualifiers
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 of lymphedema that is not completely reversed by decongestion therapy modalities. (Not applicable for patients with lymphedema of the head and neck)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Symani Surgical System
Treatment groups
180 Participants
are divided into 1 treatment groupLocations
1Saint Vincent's Hospital Melbourne3065, MelbourneVictoria, Australia
Sponsors and collaborators
MMI (Medical Microinstruments, Inc.)
Lead sponsor
Source ClinicalTrials.gov