PRIMO Post-Market Clinical Follow Up Study

MMI (Medical Microinstruments, Inc.)

Status: Completed

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

Treatments: Device: Symani Surgical System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04843436

CDC-00031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 427 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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427 participants in 1 patient group

Robotic Assisted Microsurgery

Experimental group

Description:

Patients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use.

Treatment:

Device: Symani Surgical System