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RECRUITING
NCT06725030

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

Sponsor: MMI (Medical Microinstruments, Inc.)

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

OBSERVATIONAL

Enrollment

455

Start Date

2025-09-22

Completion Date

2027-12-01

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

DEVICE

Symani Surgical System

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

Locations (4)

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

Cleveland Clinic

Cleveland, Ohio, United States