None listed
Conditions
Interventions
Procedure/Surgery : This is a single-center, prospective, exploratory clinical trial designed to evaluate the therapeutic efficacy and safety of micro-anastomosis using the Symani® Surgical System for
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients who, between the IRB approval date and December 31, 2026, are diagnosed through clinical evaluation and imaging studies (e.g., Ultrasonography, ICG Lymphangiography) as requiring anastomosis of vessels or nerves smaller than 1mm at the Department of Plastic Surgery, Asan Medical Center. - Patients undergoing free flap reconstruction that requires perforator-to-perforator anastomosis. - Patients with lymphedema indicated for surgical intervention requiring lymphatic-to-venous anastomosis (LVA) using the supermicrosurgical technique.
Exclusion criteria
Exclusion criteria: - Patients aged 18 and under, and 80 and over - Cases where anastomosis is unfeasible due to the intraoperative discovery of moderate to severe vascular calcification. - Cases where no lymphatic flow is identified on ICG lymphangiography. - Individuals who cannot fully comprehend the study’s purpose, procedures, or informed consent, or who do not provide written consent to participate. - Patients with severe local tissue reactions at the planned anastomosis site due to infection, tissue necrosis, or a history of radiation therapy. - Patients currently receiving anticoagulant therapy with a high risk of bleeding that limits surgical intervention. - Women who are pregnant or breastfeeding. - Patients who have undergone other surgical interventions or anastomosis at the same site within the last 3 months. - Any other medical or psychological conditions that, in the investigator’s judgment, could significantly interfere with the evaluation or outcomes of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of anastomotic patency performed immediately after surgery I | — |
Secondary
| Measure | Time frame |
|---|---|
| Flap survival rate;Volume change rate;MoCA and MMSE scores for LRBD patients at 1 and 3 months post-op;Occurrence and timing of revision surgery;Reasons for revision surgery and its success rate;Incidence of surgery-related complications;Length of stay from the date of surgery to discharge | — |
Countries
Korea, Republic of
Contacts
Public Contactjoonpio Hong
Asan Medical Center
Outcome results
None listed