Primary Endpoint Sample Clauses
Primary Endpoint. 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. The statistical hypothesis is: H0: δT - δC ≥ 0.9[21, 22] H1: δT - δC < 0.9 [21, 22], where δ is the change from baseline (worst pain experienced within 1 month of screening visit) to 6-month on VAS for the appropriate treatment group. Secondary Endpoints: To assess efficacy and safety outcomes following XXXX or TEP laparoscopic groin hernia (femoral and inguinal) repair by LiquiBand FIX8® compared to AbsorbaTack™ by evaluating the following: • Recurrence rate in subjects following laparoscopic (TEP and XXXX) groin hernia repair by LiquiBand FIX8® or control (AbsorbaTack™) at 2 weeks, 3 months, 6 months, and 12 months. The statistical hypothesis for the recurrence rate at 6 months is: H0: qT – qC ≥ 10%[25] H1: qT – qC < 10%[25], where q is the recurrence rate at 6 months for the appropriate treatment group. • Rate of successful hernia mesh fixation in subjects undergoing TEP and XXXX laparoscopic groin hernia repair. The statistical hypothesis is: H0: pC - pT ≥ 10% H1: pC - pT < 10%, where p is the rate of successful hernia mesh fixation at time of surgery for the appropriate treatment group. • Rate of successful peritoneal closure in subjects undergoing laparoscopic XXXX hernia repair. The statistical hypothesis is: H0: πC - πT ≥ 15% H1: πC - πT < 15%, where π is the rate of peritoneal closure at time of surgery for the appropriate treatment group. • Quality of Life assessed by the Carolinas Comfort Scale (CCS) Questionnaire prior to surgery and at 7 days, 14 days, 1 month, 3 months, 6 months, 9 months and 12 months following laparoscopic (TEP and XXXX) groin hernia repair.
Primary Endpoint. The primary endpoint of this study is HDSS score reduction from a 3 or 4 at baseline to a 1 or 2 at 30 days post-treatment #2.
Primary Endpoint. The primary study endpoint is to assess the difference in pain level between baseline and the 9 month follow-up as determined by VAS. Active and placebo arms will be compared to determine treatment effect. The primary analysis will be conducted in the efficacy analysis dataset. A secondary analysis will be conducted in the ITT analysis dataset, and further analyses conducted as necessary to explore any inconsistency between the two results.
Primary Endpoint. The primary endpoint is based on the mean reduction in total length of operative time. Operative time will be determined by the official recorded operative notes.
Primary Endpoint. The primary endpoint will be the proportion of subjects who achieve wound closure by or at 12-weeks post treatment with MIRODERM.
Primary Endpoint. The primary endpoint will be the responder rate for lip fullness on the LFS2, which is defined as the proportion of subjects who show ≥ 1-point improvement on the LFS2 compared to baseline assessment, at Day 30 after last treatment received.
Primary Endpoint. Change in DENV viral load (DENV RNA as measured by RT-qPCR) from baseline
Primary Endpoint. The primary outcome measure will be the tolerability of the application of the stem cell recovery complex (SCR Complex™) and a botanical lipid based occlusive (Bio Cel™) as compared with standard of care following fractional RF treatments.
Primary Endpoint. Mean change in PED height at weeks 24 and 52.Proportion of patients with resolution of PED at weeks 24 and 52.
Primary Endpoint. The main goal of the prospective pilot study is to identify factors, processes and health care infrastructures that may predict at different points in time and in the long-term the patient's resilience to the physically and psychologically stressful their physical wellbeing and the psychological outcomes of the cancer event.