Study Objectives and Endpoints Sample Clauses

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 ▇▇▇▇) 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. Secondary 1 To evaluate the incidence of hernia recurrence in patients following laparoscopic (TEP and ▇▇▇▇) hernia repair using LiquiBand FIX8® or control device. The incidence of hernia recurrence in patients following laparoscopic (TEP and ▇▇▇▇) groin hernia repair by LiquiBand FIX8® or control (AbsorbaTack™) will be assessed by physical examination at 2 weeks, 3 months, and 6 months. Suspected hernia recurrence will also be evaluated at any time following surgery and up to the 12 month follow up visit if reported by the subject. Suspected hernia recurrence will be confirmed by ultrasound imaging following physical examination. Secondary 2 To compare the use of LiquiBand FIX8® to control device for mesh fixation at time of surgery. LiquiBand FIX8® will be required to successfully fix hernia mesh in patients undergoing TEP and ▇▇▇▇ laparoscopic groin hernia repair, at a rate non-inferior to control device (AbsorbaTack™) in order to meet this end point. Successful mesh fixation would not require any additional fixation by alternate fixation device. Unsuccessful mesh fixation is defined as requiring the use of an alternative fixation device or additional procedure to achieve adequate fixation. Secondary 3 To compare the use of LiquiBand FIX8® to control devices for the approximation of the peritoneum (▇▇▇▇ repairs only) at time of ...