Not yet recruiting NCT07427823

Evaluation of MUSA-3 in Microsurgical Anastomoses

No phase Interventional Anastomosis, Surgical

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Robot-assisted microsurgical anastomoses.
Who it may be relevant to: Registry conditions: Anastomosis, Surgical. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

Clinical Safety and Performance Evaluation of MUSA-3 in Microsurgical Anastomoses

This study is conducted to evaluate the safety and performance of robot-assisted microsurgical anastomoses with the MUSA-3 system.

Safety: device-related adverse events (AEs) [Time frame: Intraoperatively and through the 30-day post-procedure period]
Performance: conversion rate to manual procedure [Time frame: Intraoperatively]
Clinical performance: vessel patency rate [Time frame: Intraoperatively]

Secondary outcome measures (2)

Patient age ≥ 18 years.
Patients requiring procedures involving micro-anastomosis of small anatomical structures-such as blood vessels, nerves, or lymphatic vessels-in free flap, lymphatic, or peripheral nerve surgery.
Patients who have been selected by the research team at the Clinical Center as appropriate candidates for treatment with MUSA-3 in accordance with the IFU.
Able to give informed consent before participating in the study.
Provision of signed and dated informed consent form.

Subject participates in a potentially confounding drug or device trial during the course of the study.
Patients that are pregnant or breastfeeding.

For Lymphedema patients:

≥ISL (International Society of Lymphology) Stage III lymphedema
History of marcaine or indocyanine green allergy
Non-viable lymphatic system as determined by ICG lymphatic mapping using near infrared camera

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Center list to be confirmed — check the primary protocol.

NCT: NCT07427823 · NL-011051