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NCT Number: NCT07427823

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.

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Key information

Conditions

Anastomosis, Surgical

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-assisted microsurgical anastomoses

Device

First in human study

Primary outcomes

  1. Safety: device-related adverse events (AEs)

    Time frame: Intraoperatively and through the 30-day post-procedure period

  2. Performance: conversion rate to manual procedure

    Time frame: Intraoperatively

  3. Clinical performance: vessel patency rate

    Time frame: Intraoperatively

Secondary outcomes

  1. Anastomosis quality (SAMS score)

    Time frame: Intraoperatively

    The quality of the anastomosis assessed with the Structured Assessment of Microsurgery Skills (SAMS) score.

  2. 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.

Sponsors and collaborators

Lead sponsor

Microsure

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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