PRIMO Post-Market Clinical Follow Up Study

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Open Surgery, Blood Vessels, Lymphatic Ducts and Nerves, Free Flaps

Intervention / Treatment
-----------------
* Device: Symani Surgical System


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic Assisted Microsurgery<br>Patients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use. | Device: Symani Surgical System<br>* Robotically Assisted Microsurgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Robotic Success | Ability to complete the surgical task with Symani as intended by the surgeon | Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomosis time | Time to execute each anastomosis | Procedure | 
| Intraoperative redo | Intraoperative need to repeat anastomosis | Procedure | 
| Postoperative redo | Postoperative need to repeat anastomosis | 7 days | 
| Complications | Major or minor complications | 30 days | 
| Free Flap/Replantation Failure | Failure of the free flap or replantation | 30 days | 
| Limb volume reduction (for lymphatic surgery) | Limb volume reduction | 24 weeks | 
| Warm ischemia time | Time for warm ischemia | Procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microsurgery, RASM, free flap, lymphatic ducts, Symani