A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Recruiting now
Conditions studied: Open Surgery, Lymphedema, Free Tissue Transfer, Microsurgery, Anastomosis, Surgical
In brief
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.
Key facts
- Study ID
- NCT06725030
- Run by
- MMI (Medical Microinstruments, Inc.)
- People needed
- 455
- Starts
- 2025-09-22
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-07-13
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Cedars Sinai Medical Center — Beverly Hills, California, United States (enrolling)
- Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
- Tampa General Hospital — Tampa, Florida, United States (enrolling)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- Erie County Medical Center — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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