A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis

The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphatic surgery. The primary endpoints are: * Effectiveness: Clinical Success, defined as intraoperative anastomosis patency. * Safety: Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee. Participants will receive treatment as standard of care and be asked to: * Allow the researchers to access and use their information. * If participants are undergoing a therapeutic lymphatic procedure, they will be asked to complete a questionnaire and undergo lymphedema volume assessments as part of the study. If participants are undergoing a prophylactic lymphatic procedure, they will only be asked to undergo limb volume assessments. * Participants will be asked to comply with the follow-up visits as outlined in the protocol.

NCT Number	NCT06628219
Lead Sponsor	MMI (Medical Microinstruments, Inc.)
Conditions	Open Surgery, Lymphedema, Free Tissue Transfer, Microsurgery
Enrollment	1,000 participants
Start Date	2025-02-01
Primary Completion	2026-02-01 (estimated)
Study Completion	2030-02-01 (estimated)
Updated on ClinicalTrials.gov	2024-12-10