NCT04843436

PRIMO Post-Market Clinical Follow Up Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 427 (actual)
• Sponsor: MMI (Medical Microinstruments, Inc.) · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Open Surgery
• Blood Vessels, Lymphatic Ducts and Nerves
• Free Flaps

Interventions

Type	Name	Description
DEVICE	Symani Surgical System	Robotically Assisted Microsurgery

Timeline

• Start date: 2021-04-13
• Primary completion: 2025-02-06
• Completion: 2025-07-18
• First posted: 2021-04-13
• Last updated: 2026-01-05

Locations

10 sites across 7 countries: Austria, Belgium, Finland, Germany, Italy, Spain, Switzerland