PRIMO Post-Market Clinical Follow Up Study

NCT ID: NCT04843436

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 427 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-13
• Study Completion Date: 2025-07-18

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Symani Surgical System

Intervention Type: DEVICE

Robotically Assisted Microsurgery

Interventions

Symani Surgical System

Robotically Assisted Microsurgery

Intervention Type: DEVICE

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MMI (Medical Microinstruments, Inc.)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Innocenti, Prof.

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli Bologna

Locations

LKH Salzburg, Universitätsklinik für Mund-, Kiefer- und Gesichtschirurgie

Salzburg, , Austria

Universitair Ziekenhuis Brussel

Brussels, , Belgium

Helsinki University Hospital

Helsinki, , Finland

Klinik für Mund-, Kiefer- und Gesichtschirurgie UKSH Kiel

Kiel, , Germany

BG Kliniken Ludwigshafen

Ludwigshafen, , Germany

Fachklinik Hornheide

Münster, , Germany

Istituto Ortopedico Rizzoli

Bologna, , Italy

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

University Hospital Zurich

Zurich, , Switzerland

Countries

Austria; Belgium; Finland; Germany; Italy; Spain; Switzerland

Other Identifiers

CDC-00031

Identifier Type: -

Identifier Source: org_study_id