Evaluating the Symani Surgical System for Microsurgical Lymphatic Reconstruction in Adults with Head and Neck Lymphedema

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Symani Surgical System for microsurgical anastomosis during open lymphatic reconstruction in adults with head and neck lymphedema. This study focuses on patients who need delicate vessel connections between 0.1 and 2.5 mm in size as part of reconstructive surgery to improve lymphatic drainage in the head and neck region. Participants will undergo surgery using the Symani Surgical System, a device designed to assist with microsurgical techniques during these open procedures. The study includes adults 22 years and older who have clinical indications for microsurgical anastomosis combined with lymphatic reconstruction. Key study periods include the surgical procedure and follow-up assessments lasting up to six months post-procedure. During the study, participants will have pre-operative visits, the surgical procedure, and follow-up assessments at set intervals up to six months. Researchers will monitor anastomosis patency, device-related adverse events, changes in lymphatic flow and lymphedema severity using established rating scales and symptom inventories. Safety will be assessed through adverse event rates and readmission rates up to 30 days after surgery. Participants adherence to self-care regimens and use of manual lymph drainage or compression garments will also be tracked throughout the study.

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