PRIMO Post-Market Clinical Follow Up Study

Open Surgery Clinical Trial

— PRIMO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04843436
• Other study ID #: CDC-00031
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2023
• Source: MMI Spa
• Contact: Elisa Scaccianoce
• Phone: +39 050 879692
• Email: elisa.scaccianoce[@]mmimicro.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: December 31, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Symani Surgical System
Robotically Assisted Microsurgery

Locations

Country	Name	City	State
Austria	LKH Salzburg, Universitätsklinik für Mund-, Kiefer- und Gesichtschirurgie	Salzburg
Belgium	Universitair Ziekenhuis Brussel	Brussel
Germany	Klinik für Mund-, Kiefer- und Gesichtschirurgie UKSH Kiel	Kiel
Germany	Fachklinik Hornheide	Münster
Italy	Istituto Ortopedico Rizzoli	Bologna
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Switzerland	University Hospital Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
MMI Spa

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Robotic Success	Ability to complete the surgical task with Symani as intended by the surgeon	Procedure
Secondary	Anastomosis time	Time to execute each anastomosis	Procedure
Secondary	Intraoperative redo	Intraoperative need to repeat anastomosis	Procedure
Secondary	Postoperative redo	Postoperative need to repeat anastomosis	7 days
Secondary	Complications	Major or minor complications	30 days
Secondary	Free Flap/Replantation Failure	Failure of the free flap or replantation	30 days
Secondary	Limb volume reduction (for lymphatic surgery)	Limb volume reduction	24 weeks
Secondary	Warm ischemia time	Time for warm ischemia	Procedure