NCT07427823

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

February 9, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2026

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 9, 2026

Last Update Submit

February 16, 2026

Conditions

Anastomosis, Surgical

Outcome Measures

Primary Outcomes (3)

  • Safety: device-related adverse events (AEs)

    Intraoperatively and through the 30-day post-procedure period

  • Performance: conversion rate to manual procedure

    Intraoperatively

  • Clinical performance: vessel patency rate

    Intraoperatively

Secondary Outcomes (2)

  • Anastomosis quality (SAMS score)

    Intraoperatively

  • Anastomosis time

    Intraoperatively

Study Arms (1)

Robot-assisted anastomoses

EXPERIMENTAL
Device: Robot-assisted microsurgical anastomoses

Interventions

Robot-assisted microsurgical anastomosesDEVICE

First in human study

Robot-assisted anastomoses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 23, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

September 28, 2026

Study Completion (Estimated)

September 28, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02