PRIMO Post-Market Clinical Follow Up Study

Launched by MMI (MEDICAL MICROINSTRUMENTS, INC.) · Apr 12, 2021

Keywords

ClinConnect Summary

The PRIMO Post-Market Clinical Follow-Up Study is looking at the safety and effectiveness of a robotic system called Symani, which helps surgeons perform delicate microsurgery on small structures like blood vessels, lymphatic ducts, and nerves. This study is specifically focused on patients who need reconstructive surgeries due to various conditions, such as injuries or congenital issues. The trial is currently recruiting participants aged 18 and older who have been identified by their surgeons as suitable candidates for this type of robotic-assisted surgery.

To participate, individuals must agree to undergo surgery with the Symani system and provide informed consent. However, certain criteria may exclude individuals from joining, such as having significant bleeding disorders, certain heart or respiratory issues, or being part of another clinical trial recently. Participants can expect to contribute to valuable data that may help improve future surgical procedures while receiving care for their own health needs.

Gender

ALL

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 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