Not Yet RecruitingNot Applicable

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

30 participantsStarted 2026-04-28

Plain-language 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.

Who can participate

Age range22 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Intraoperative anastomosis patency prior to closure.

Timeframe: The duration of the participants' index procedure.

Freedom from device-related adverse events

Timeframe: The duration of the participants' index procedure through 30 days.

Trial details

NCT IDNCT07311876

SponsorMMI (Medical Microinstruments, Inc.)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05-28

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