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Completed
NCT04843436
PRIMO Post-Market Clinical Follow Up Study
Conditions: Open Surgery, Blood Vessels, Lymphatic Ducts and Nerves, Free Flaps
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: NA
Enrollment: 427
Sponsor: MMI (Medical Microinstruments, Inc.)
Location: LKH Salzburg, Universitätsklinik für Mund-, Kiefer- und Gesichtschirurgie Salzburg
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.
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 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.
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 study.
* Subjects belonging to vulnerable populations or ineligible to participate for other reasons by the PI at a Clinical Center.
* Subjects with pacemaker
Source: ClinicalTrials.gov (NCT04843436). StuddyBuddy aggregates publicly available trial information.