Evaluating the Safety and Performance of the OTTAVA Robotic System for Elective Inguinal Hernia Repair in Adults

What this Trial Is About

Researchers are evaluating the safety and performance of the OTTAVA System in people undergoing robotic-assisted inguinal hernia repair IHR. The study focuses on how well the OTTAVA System works during the surgery and tracks any complications or issues through 30 days after the procedure. The main goal is to see how many surgeries are completed without switching to another method and to monitor serious complications related to the device or procedure. Participants will have their inguinal hernia repaired using the OTTAVA Robotic System. After surgery, they will be discharged from the hospital and then followed up according to the usual care at their institution. A final follow-up visit will occur 30 days after the procedure to assess recovery and any complications. During the study, participants will be monitored for any adverse events, device malfunctions, blood transfusions, hospital readmissions, reoperations, and mortality within 30 days post-procedure. The study will also record the length of hospital stay and total operative time. This monitoring ensures detailed safety and performance data are collected throughout the 30-day postoperative period.

Safety and Performance of the OTTAVA System in Participants Undergoing Inguinal Hernia Repair