RecruitingNot ApplicableNCT07311876

Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani

Sponsor

MMI (Medical Microinstruments, Inc.)

Enrollment

30 participants

Start Date

Jun 19, 2026

Study Type

INTERVENTIONAL

Conditions

Lymphedema Lymphedema of Face Internal Lymphedema External Lymphedema Lymphedema of Neck

Summary

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

Min Age: 22 Years

Inclusion Criteria8

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
Patient has been compliant with complete decongestive therapy (CDT) for at least 4 weeks
Patient has undergone lymphatic mapping of the head and neck and functional lymphatic structures for reconstruction have been identified
Investigator deems the candidate acceptable for lymphatic reconstruction with a robotic-assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU)
Willingness to comply with recommended regimen of self-care, with consistent use of manual lymph drainage and/or appropriately sized compression garments from screening through the entire study duration (through the 6-month follow-up visit).

Exclusion Criteria14

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
Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
Currently receiving chemotherapy or radiation therapy (uncontrolled tumor)
A history of malignancy or cancer treatment within the past 6 months (tumor control)
Patient with unsatisfactory manual lymphatic drainage and/or compression garments for at least six months
Patient with prior lymphatic reconstruction in the targeted head \& neck area
Patient's lymphatic disease is due to lipedema
Patients with other medical conditions that could result in symptoms which overlap symptoms of lymphedema (e.g., thrombosis in the external or internal jugular vein)
Current infection in the head \& neck area in which lymphedema is present
Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes
Patient is ineligible to participate for other reasons in the judgement of the investigator