PRIMO Post-Market Clinical Follow Up Study
- Conditions
- Free FlapsBlood Vessels, Lymphatic Ducts and NervesOpen Surgery
- Registration Number
- NCT04843436
- Lead Sponsor
- MMI (Medical Microinstruments, Inc.)
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 429
- 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 PI at the Clinical Center as appropriate candidates for treatment with Symani System in accordance with the IFU.
- Subjects who fit the criteria to perform surgery requiring reconstructions using free flaps, replantation, lymphatic reconstructions.
- Subjects who agree to have the surgery and the anaesthesia.
- Subjects who voluntarily decide to participate in this study with the surgery performed with the aid of the Symani System and sign the Informed Consent Form.
- 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 study.
- Subjects belonging to vulnerable populations or ineligible to participate for other reasons by the PI at a Clinical Center.
- Subjects with pacemaker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Procedure Robotic Success Procedure Ability to complete the surgical task with Symani as intended by the surgeon
- Secondary Outcome Measures
Name Time Method Limb volume reduction (for lymphatic surgery) 24 weeks Limb volume reduction
Anastomosis time Procedure Time to execute each anastomosis
Intraoperative redo Procedure Intraoperative need to repeat anastomosis
Complications 30 days Major or minor complications
Free Flap/Replantation Failure 30 days Failure of the free flap or replantation
Postoperative redo 7 days Postoperative need to repeat anastomosis
Warm ischemia time Procedure Time for warm ischemia
Trial Locations
- Locations (10)
LKH Salzburg, Universitätsklinik für Mund-, Kiefer- und Gesichtschirurgie
🇦🇹Salzburg, Austria
Universitair Ziekenhuis Brussel
🇧🇪Brussel, Belgium
Helsinki University Hospital
🇫🇮Helsinki, Finland
Klinik für Mund-, Kiefer- und Gesichtschirurgie UKSH Kiel
🇩🇪Kiel, Germany
BG Kliniken Ludwigshafen
🇩🇪Ludwigshafen, Germany
Fachklinik Hornheide
🇩🇪Münster, Germany
Istituto Ortopedico Rizzoli
🇮🇹Bologna, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Italy
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
University Hospital Zurich
🇨🇭Zürich, Switzerland
LKH Salzburg, Universitätsklinik für Mund-, Kiefer- und Gesichtschirurgie🇦🇹Salzburg, Austria