NCT06628219

A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis

A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis: Expanding Access to Care in Free Tissue Transfer Surgery and Lymphatic Surgery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: MMI (Medical Microinstruments, Inc.) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphatic surgery. The primary endpoints are: * Effectiveness: Clinical Success, defined as intraoperative anastomosis patency. * Safety: Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee. 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 therapeutic lymphatic procedure, they will be asked to complete a questionnaire and undergo lymphedema volume assessments as part of the study. If participants are undergoing a prophylactic lymphatic procedure, they will only be asked to undergo limb volume assessments. * Participants will be asked to comply with the follow-up visits as outlined in the protocol.

Conditions

• Open Surgery
• Lymphedema
• Free Tissue Transfer
• Microsurgery

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: 2025-02-01
• Primary completion: 2026-02-01
• Completion: 2030-02-01
• First posted: 2024-10-04
• Last updated: 2024-12-10

Regulatory

• FDA-regulated device study