A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
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 lymphedema 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

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

1,000 Participants
are divided into 1 treatment group

Locations

This trial has no locations