Blood Vessels, Lymphatic Ducts and Nerves, Free Flaps, Open Surgery
Conditions
Keywords
microsurgery, RASM, free flap, lymphatic ducts, Symani
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.
Interventions
DEVICESymani Surgical System
Robotically Assisted Microsurgery
Sponsors
MMI (Medical Microinstruments, Inc.)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Robotic Success | Duration of the robotic anastomotic portion of the participants index procedure | Ability to complete the surgical task with Symani as intended by the surgeon |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anastomosis Time | Procedure | 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. |
| Intraoperative Redo | Procedure | Intraoperative need to repeat anastomosis |
| Percentage of Participants With Postoperative Redo Within 7 Days | 7 days | Post-operative redos were identified as the need to return to the operating room to explore anastomosis. |
| Surgeon Assessment of Robotic Usability | 30 days | 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. |
| Free Flap Survival at Discharge | 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. |
| Limb Volume Reduction (for Lymphatic Surgery) | 24 weeks | Limb volume reduction |
| Warm Ischemia Time | Procedure | Time for warm ischemia |
Countries
Austria, Belgium, Finland, Germany, Italy, Spain, Switzerland
Contacts
PRINCIPAL_INVESTIGATORMarco Innocenti, Prof.
Istituto Ortopedico Rizzoli Bologna
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 53.8 years STANDARD_DEVIATION 13.39 |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Black | 10 Participants |
| Race/Ethnicity, Customized Caucasian | 400 Participants |
| Race/Ethnicity, Customized Other | 6 Participants |
| Region of Enrollment Austria | 6 participants |
| Region of Enrollment Belgium | 73 participants |
| Region of Enrollment Finland | 26 participants |
| Region of Enrollment Germany | 191 participants |
| Region of Enrollment Italy | 43 participants |
| Region of Enrollment Spain | 83 participants |
| Region of Enrollment Switzerland | 5 participants |
| Sex: Female, Male Female | 279 Participants |
| Sex: Female, Male Male | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 274 | 0 / 129 | 0 / 12 |
| other Total, other adverse events | 51 / 274 | 9 / 129 | 2 / 12 |
| serious Total, serious adverse events | 20 / 274 | 2 / 129 | 0 / 12 |
Outcome results
None listed