Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorMMI (Medical Microinstruments, Inc.)
About this trial
The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during open lymphatic reconstruction in the head and neck.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 22 years of age
Patients with acquired head and neck lymphedema with external lymphedema or both external and internal lymphedema
Patient agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic-assisted procedure
Patient has a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with lymphatic reconstruction of the head and neck
Disqualifiers
Patient who is incapable and/or unwilling to provide informed consent
Patients with irreversible head and neck lymphedema, defined as stage 3 of the MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale
Active systemic infection under treatment with intravenous antibiotics
Clinically significant cardiovascular, digestive, respiratory, endocrine, 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 investigator's discretion
Trial design
Design model
Single group
Treatments tested in this trial
Symani Surgical System
DeviceSymani® Surgical System is intended to perform surgical techniques during open microsurgical procedures.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Head and Neck LymphedemaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Intraoperative anastomosis patency prior to closure.
Intraoperative anastomosis patency prior to closure will be measured for each robotic anastomosis using indocyanine green (ICG) fluorescence imaging and will be evaluated prior to closure of the procedure site during the index procedure.
Time frame
The duration of the participants' index procedure.2
Freedom from device-related adverse events
All adverse events will be evaluated from the start of the index procedure through 30 days post index procedure.
Time frame
The duration of the participants' index procedure through 30 days.Secondary outcomes
1
Change in flow pathways
Change in flow pathways will be assessed by an ICG lymphangiography
Time frame
From the pre-operative visit through 6 months post index procedure.2
Change in MD Anderson Lymphedema Rating Scale for facial lymphedema
Scale ranges from 0-3, the higher score indicating worse disease state.
Time frame
From the pre-operative visit through 6 months post index procedure.3
Assessment of Lymphedema of the Head and Neck Area (ALOHA) method for lymphedema measurement
Time frame
From the pre-operative visit through 6 months post index procedure.4
Change in Head and Neck Lymphedema and Fibrosis Symptom Inventory
It contains 33 items (symptoms) which are answered Yes or No. If the response is Yes to any given item, the patient is asked to rate the intensity of the symptom on a 5-point Likert scale. Each symptom then receives a score ranging from 0 (does not experience the symptom) to 5 (experiences the symptom with severe intensity).
Time frame
From the pre-operative visit through 6 months post index procedure.Sponsors and contacts
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Source ClinicalTrials.gov