Micro anastomoses A microsurgical technique where surgeons reconnect very small anatomical structures, such as blood or lymphatic vessels or nerves
Conditions
Interventions
The MUSA-3 is a telemanipulation device developed to stabilize and downscale the surgeon’s hand movements during open (super)microsurgery. Using the Product, the outcome of existing procedures may imp
Sponsors
MicroSure B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following 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 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
Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study:Subject participates in a drug or device trial during the course of the study. Patients who 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: Incidence of all adverse events (AEs) intraoperatively and through the 30-day post-procedure period. All AEs are followed until their clinical resolution or steady state, irrespective of the number of days in the post-op period (if resolution exceeds 30 days). If possible, the cause of every AE is determined (robot-, patient illness-, procedure- or other circumstances-related).Performance: Successful completion of the procedure using the MUSA-3 without conversion to standardmanual surgery (conversion rate to manual). The reason for the conversion is documented: 1) a robot-related technical problem, or 2) a patient/procedure-related inabilityproblem (due to anatomy, position, or pathology).Clinical performance: Vessel patency intraoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| To provide important surgical information the following secondary outcome measures are gathered: Anastomosis quality (SAMS score) Anastomosis time (in minutes) | — |
Countries
Germany, Netherlands
Contacts
Public ContactE.P. Elschot
Microsure BV
Outcome results
None listed