Evaluation of MUSA-3 in Microsurgical Anastomoses

February 16, 2026 updated by: Microsure

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot-assisted anastomoses
Device: Robot-assisted microsurgical anastomoses
First in human study

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anastomosis quality (SAMS score)
Time Frame: Intraoperatively
The quality of the anastomosis assessed with the Structured Assessment of Microsurgery Skills (SAMS) score.
Intraoperatively
Anastomosis time
Time Frame: Intraoperatively
Duration of the full anastomosis from the moment of piercing the vessel wall for the first stitch until the thread of the last stitch is cut.
Intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Microsure

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

September 28, 2026

Study Completion (Estimated)

September 28, 2026

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • NL-011051

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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