100
Participants
Start Date
September 30, 2025
Primary Completion Date
September 30, 2026
Study Completion Date
March 31, 2028
Symani® Surgical System
"Robotic-assisted surgery consists of participants who undergo nerve coaptation with the Symani Surgical System, according to the Instruction for Use (IFU). In order for the surgery to be considered a robotic assisted surgery, the participants must be randomized to the RAS group which will include:~* Participants where all nerve coaptations were performed entirely with Symani.~* Participants who underwent a hybrid procedure, where a coaptation was commenced using Symani but a switch to manual suturing occurred during the procedure"
Manual Surgery
"Manual surgery consists of participants who undergo nerve coaptation through manual techniques by a surgeon using handheld instruments without robotic assistance. In order for the surgery to be considered a manual surgery, the participants must be randomized to the MS group which will include:~* Participants where all nerve coaptations were performed entirely manually.~* Participants who underwent a hybrid procedure, where a coaptation was commenced using manual suturing but a switch to Symani occurred during the procedure."
BG Klinik Ludwigshafen, Ludwigshafen
Lead Sponsor
MMI (Medical Microinstruments, Inc.)
INDUSTRY