RecruitingNCT06725030

A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons

PRECISE: A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons


Sponsor

MMI (Medical Microinstruments, Inc.)

Enrollment

455 participants

Start Date

Sep 22, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. The primary endpoints are: * Effectiveness- Rate of intraoperative anastomosis patency at first attempt. * Safety- Freedom from device-related adverse events. Participants will receive treatment as standard of care and be asked to: * Allow the researchers to access and use their information. * If participants are undergoing a lymphedema procedure, they will be asked to undergo a questionnaire as part of the study. * Participants will be asked to comply with the follow-up visits and complete all study procedures/questionnaires as outlined in the protocol.


Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Symani Surgical System for people with anastomosis, surgical, free tissue transfer, and other related conditions. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESymani Surgical System

The Symani Surgical System (Symani) is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.


Locations(6)

Cedars Sinai Medical Center

Beverly Hills, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Tampa General Hospital

Tampa, Florida, United States

Erie County Medical Center

Buffalo, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT06725030


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