Post Market Clinical Follow up Study aimed to collect clinical data on safety and efficacy of Robotically Assisted System called Symani to perform microsurgery techniques such as anastomosis, suturing and ligation for open surgery procedures on small anatomical structures such as blood vessels, lymphatic ducts and nerves.
PMCF study aimed to monitor the safety, usability, performance and long-term efficacy of Symani. Furthermore, it will permit to detect potential emerging risks related to safety on the basis of clinical evidence through the observation of patients who have undergone microsurgical reconstructions using the Symani Surgical System in the usual setting of standard surgical practice.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
427
Robotically Assisted Microsurgery
LKH Salzburg, Universitätsklinik für Mund-, Kiefer- und Gesichtschirurgie
Salzburg, Austria
Universitair Ziekenhuis Brussel
Brussels, Belgium
Helsinki University Hospital
Helsinki, Finland
Klinik für Mund-, Kiefer- und Gesichtschirurgie UKSH Kiel
Procedure Robotic Success
Ability to complete the surgical task with Symani as intended by the surgeon
Time frame: Duration of the robotic anastomotic portion of the participants index procedure
Anastomosis Time
Time to execute each fully robotic anastomosis. \*Please note - three participants underwent a Free Flap and LVA surgery and therefore are accounted for in each cohort.
Time frame: Procedure
Intraoperative Redo
Intraoperative need to repeat anastomosis
Time frame: Procedure
Percentage of Participants With Postoperative Redo Within 7 Days
Post-operative redos were identified as the need to return to the operating room to explore anastomosis.
Time frame: 7 days
Surgeon Assessment of Robotic Usability
Surgeons were asked to complete a questionnaire for each patient operated on using the study device. Success was defined as a response of complete or partial procedure success.
Time frame: 30 days
Free Flap Survival at Discharge
This effectiveness endpoint is assessed only for free flap procedures undertaken in the FAS. Subjects were assessed at the time of discharge for free flap survival status.For patients with free flap procedures, the average hospital stay was 11.9 days.
Time frame: discharge
Limb Volume Reduction (for Lymphatic Surgery)
Limb volume reduction
Time frame: 24 weeks
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Kiel, Germany
BG Kliniken Ludwigshafen
Ludwigshafen, Germany
Fachklinik Hornheide
Münster, Germany
Istituto Ortopedico Rizzoli
Bologna, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
University Hospital Zurich
Zurich, Switzerland
Warm Ischemia Time
Time for warm ischemia
Time frame: Procedure