Study of Robotic Repair of Ventral or Inguinal Hernias Using OviTex Mesh to Assess Safety and Recurrence

What this Trial Is About

Researchers are evaluating the post-operative complications and the recurrence of hernias in patients undergoing robotic repair of ventral or inguinal hernias using the OviTex reinforced tissue matrix. This single-arm study focuses on understanding the outcomes following this specific surgical mesh treatment. Up to 160 participants will be enrolled across multiple sites to gather comprehensive data on these surgical procedures. All participants will receive the OviTex reinforced tissue matrix as part of their hernia repair surgery using a robotic approach. Different types of OviTex implants may be used depending on the hernia, including OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR. The size of the implant varies by type, with some size limits for certain products. The study does not include a comparison group and focuses solely on patients treated with OviTex. Participants will be monitored for early and late surgical site occurrences and wound-related events, as well as post-operative complications within the first three months and beyond. Patient-reported outcomes such as quality of life and pain will be assessed up to 24 months after surgery. Hernia recurrence will also be evaluated at 90 days and at 12 and 24 months post-operation. The study involves follow-up visits and questionnaires to track these outcomes over time, with participation lasting up to two years.

Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh