Monitoring the safety and effectiveness of the Symani Surgical System for microsurgery

Post-Market, Non-Randomized, Multicentre PMCF Study to Monitor the Safety and Performance of Symani System in Microsurgical Reconstructive Procedures in a Real Life Setting

This study is testing the safety and effectiveness of a robotic system called Symani for performing delicate surgeries on small body parts like blood vessels and nerves.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: MMI Spa (industry)
• Locations: 10 sites (Salzburg and 9 other locations)
• Trial ID: NCT04843436 on ClinicalTrials.gov

What this trial studies

This post-market clinical follow-up study aims to collect clinical data on the safety and efficacy of the Robotically Assisted System known as Symani for performing microsurgical techniques such as anastomosis, suturing, and ligation. The study will monitor the usability and long-term performance of the Symani system in standard surgical practice, focusing on small anatomical structures like blood vessels, lymphatic ducts, and nerves. By observing patients who have undergone microsurgical reconstructions, the study seeks to identify any potential emerging risks related to safety based on clinical evidence.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 who require reconstructive surgery and are deemed suitable for microsurgical reconstruction by their surgeon.

Not a fit: Patients with bleeding or coagulation disorders may not benefit from this study due to the nature of the surgical procedures involved.

Why it matters

Potential benefit: If successful, this study could enhance the safety and effectiveness of microsurgical procedures, leading to improved patient outcomes.

How similar studies have performed: Other studies utilizing robotic-assisted surgical systems have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Male and female patients aged \>18
* Patients who need a reconstructive procedure and a microsurgical reconstruction is deemed the best option by the plastic, orthopedic or other surgeon in response to a post-oncological, post-traumatic or congenital tissue defect or to treat lymphedema.
* Patients who have been selected by the Clinical Registry Manager at the Clinical Center as appropriate candidates for treatment with RASM in accordance with the Instruction For Use (IFU).
* Subjects who fit the criteria to perform surgery requiring reconstructions using free flaps, replantations or lymphatic reconstructions.
* Subjects who agree to have the surgery and the anesthesia.
* Subjects who voluntarily decide to participate in this registry with the surgery performed with the aid of the RASM Surgical System and sign the Informed Consent Form

Exclusion Criteria:

* Subjects who have bleeding or coagulation disorders in the past or present.
* Any criteria that preclude prolonged anesthesia.
* History of anaphylaxis or severe complicated allergy symptoms.
* Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the data collection or the ability to comply with the protocol.
* Evidence or history of autoimmune disease or compromised immune system.
* Participation in another clinical trial within 4 weeks prior to participation in the registry.
* Subjects belonging to vulnerable populations or ineligible to participate for other reasons by a Clinical Registry Manager at a Clinical Center.
* Subjects with pacemaker

Where this trial is running

Salzburg and 9 other locations

• LKH Salzburg, Universitätsklinik für Mund-, Kiefer- und Gesichtschirurgie — Salzburg, Austria (TERMINATED)
• Universitair Ziekenhuis Brussel — Brussel, Belgium (RECRUITING)
• Helsinki University Hospital — Helsinki, Finland (RECRUITING)
• Klinik für Mund-, Kiefer- und Gesichtschirurgie UKSH Kiel — Kiel, Germany (RECRUITING)
• BG Kliniken Ludwigshafen — Ludwigshafen, Germany (NOT_YET_RECRUITING)
• Fachklinik Hornheide — Münster, Germany (RECRUITING)
• Istituto Ortopedico Rizzoli — Bologna, Italy (RECRUITING)
• Azienda Ospedaliera Universitaria Careggi — Firenze, Italy (ACTIVE_NOT_RECRUITING)
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (RECRUITING)
• University Hospital Zurich — Zürich, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Marco Innocenti, Prof. — Istituto Ortopedico Rizzoli Bologna
• Study coordinator: Clinical Operations

Conditions: Open Surgery, Blood Vessels, Lymphatic Ducts and Nerves, Free Flaps, microsurgery, RASM, free flap, lymphatic ducts, Symani