Anastomosis, Surgical
Conditions
Brief summary
This study is conducted to evaluate the safety and performance of robot-assisted microsurgical anastomoses with the MUSA-3 system.
Interventions
DEVICERobot-assisted microsurgical anastomoses
First in human study
Sponsors
Microsure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Anastomosis quality (SAMS score) | Intraoperatively | The quality of the anastomosis assessed with the Structured Assessment of Microsurgery Skills (SAMS) score. |
| Anastomosis time | 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. |
Outcome results
None listed