Health TrialsbyHealthPanel

Evaluation of MUSA-3 in Microsurgical Anastomoses

ConditionAnastomosis, Surgical
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMicrosure

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Subject participates in a potentially confounding drug or device trial during the course of the study.

Patients that are pregnant or breastfeeding.

≥ISL (International Society of Lymphology) Stage III lymphedema

History of marcaine or indocyanine green allergy

Trial design

Design model

Single group

Treatments tested in this trial

  • Robot-assisted microsurgical anastomoses

    Device

    First in human study

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Robot-assisted anastomosesExperimental treatment 1 intervention

Trial outcomes

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)

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

Time frame
Intraoperatively
2

Anastomosis time

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.

Time frame
Intraoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Microsure

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: