Study Objectives and Endpoints. This study considers the primary efficacy endpoint as well as secondary efficacy and safety endpoints for which labeling claims based on hypothesis tests are desired (see listed in Table below). The trial will be considered a success if the primary hypothesis is met for both the PP and ITT sets (details are provided in Table 3 below). Below is the list of primary and secondary endpoints: Table 3: Primary and secondary objectives and endpoints Objective Endpoint Primary 1 To compare the improvement in pain following groin hernia repair by LiquiBand FIX8® to control device as measured by Visual Analog Scale (VAS) at baseline (worst pain experienced within 1 month of screening visit) and at six months post hernia repair. Effectiveness of LiquiBand FIX8® will be assessed and compared to treatment with AbsorbaTack™ in subjects requiring laparoscopic (TEP and XXXX) hernia repair. Success will be determined by improvement in pain not inferior to control device as measured by a VAS value (0 = no pain to 10 = most pain imaginable) from baseline (worst pain experienced within 1 month of screening visit) to six months post hernia repair.
Study Objectives and Endpoints
