Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- Symani Surgical System
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
This trial has no locations
Sponsors and collaborators
MMI (Medical Microinstruments, Inc.)
Lead sponsor
Source ClinicalTrials.gov