Clinical Trial

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

Study acronym: PRECISE
Recruiting
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2024-12-05; most recent amendment 2026-07-10.
Status change: Not Yet Recruiting → Recruiting 2025-08-26
Trial Details
NCT Number NCT06725030
Lead Sponsor MMI (Medical Microinstruments, Inc.)
Conditions Open Surgery, Lymphedema, Free Tissue Transfer, Microsurgery, Anastomosis, Surgical
Enrollment 455 participants
Start Date 2025-09-22
Primary Completion 2027-09-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-13