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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Symani Surgical System
DeviceThe Symani Surgical System (Symani) is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: Free Tissue Transfer, Therapeutic Lymphatic Surgery, Prophylactic Lymphatic Surgery ParticipantsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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)2
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).Sponsors and contacts
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Source ClinicalTrials.gov