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NOT YET RECRUITING
NCT06628219
NA

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

Sponsor: MMI (Medical Microinstruments, Inc.)

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2025-02-01

Completion Date

2030-02-01

Last Updated

2024-12-10

Healthy Volunteers

No

Interventions

DEVICE

Symani Surgical System

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