PRIMO Post-Market Clinical Follow Up Study (PRIMO)

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

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.

Study Overview

• Status: Completed
• Conditions: Open Surgery; Blood Vessels, Lymphatic Ducts and Nerves; Free Flaps
• Intervention / Treatment: Device: Symani Surgical System

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.

• Study Type: Interventional
• Enrollment (Actual): 427
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • LKH Salzburg, Universitätsklinik für Mund-, Kiefer- und Gesichtschirurgie
• Belgium
  • Brussels, Belgium
    • Universitair Ziekenhuis Brussel
• Finland
  • Helsinki, Finland, 00029
    • Helsinki university hospital
• Germany
  • Kiel, Germany, 24105
    • Klinik für Mund-, Kiefer- und Gesichtschirurgie UKSH Kiel
  • Ludwigshafen, Germany, 67071
    • BG Kliniken Ludwigshafen
  • Münster, Germany, 48157
    • Fachklinik Hornheide
• Italy
  • Bologna, Italy
    • Istituto Ortopedico Rizzoli
  • Florence, Italy
    • Azienda Ospedaliera Universitaria Careggi
• Spain
  • Barcelona, Spain, 08041
    • Hospital de La Santa Creu i Sant Pau
• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic Assisted Microsurgery; 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; Robotically Assisted Microsurgery

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	Duration of the robotic anastomotic portion of the participants index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomosis Time	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.	Procedure
Intraoperative Redo	Intraoperative need to repeat anastomosis	Procedure
Percentage of Participants With Postoperative Redo Within 7 Days	Post-operative redos were identified as the need to return to the operating room to explore anastomosis.	7 days
Surgeon Assessment of Robotic Usability	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.	30 days
Free Flap Survival at 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.	discharge
Limb Volume Reduction (for Lymphatic Surgery)	Limb volume reduction	24 weeks
Warm Ischemia Time	Time for warm ischemia	Procedure

Collaborators and Investigators

• Sponsor: MMI (Medical Microinstruments, Inc.)
• Investigators: Principal Investigator: Marco Innocenti, Prof., Istituto Ortopedico Rizzoli Bologna

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2021
• Primary Completion (Actual): February 6, 2025
• Study Completion (Actual): July 18, 2025

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: free flap; microsurgery; RASM; lymphatic ducts; Symani
• Other Study ID Numbers: CDC-00031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No