NCT06725030

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 455 (estimated)
• Sponsor: MMI (Medical Microinstruments, Inc.) · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Open Surgery
• Lymphedema
• Free Tissue Transfer
• Microsurgery
• Anastomosis, Surgical

Interventions

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

Timeline

• Start date: 2025-09-22
• Primary completion: 2027-09-01
• Completion: 2027-12-01
• First posted: 2024-12-09
• Last updated: 2026-03-05

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study