Sample Size Rationale Sample Clauses

Sample Size Rationale. The results of two prospective studies were used to inform the sample size estimation. The Endobronchial Valve for Emphysema Palliation Trial (“VENT Pivotal Trial”, IDE#G020230, NCT00129584) was a multi-center, prospective, randomized, controlled study conducted at sites in both the United States and Europe to assess the safety and effectiveness of using the Zephyr EBV device for palliating symptoms associated with severe heterogeneous emphysema. Four hundred ninety two (492) participants were enrolled into the study and randomized to Zephyr EBV Treatment or medical management (control) [16,17]. The Chartis Pulmonary Assessment System study is a recently completed prospective post- market study that was conducted in Germany, The Netherlands, and Sweden. The primary objective of the study was to quantify the accuracy of the Chartis System when used to identify targeted treatment lobes as having or not having inter-lobar CV in patients with emphysema who were to be treated using endobronchial valves (26). The results of both the VENT Study and the Chartis System study showed that treatment effect with the endobronchial valve is correlated with lack of inter- lobar CV [16,17,25]. Patients in the VENT Study and in the Chartis Study who were considered to have little or no inter-lobar CV contributed the information used for the sample size estimate. Patients who have little or no lobar CV in the targeted treatment lobe are expected to be good responders to endobronchial valve treatment. For the sample size estimate, a ‘responder’ was considered to be a study participant who had >15% improved FEV1 after EBV treatment. Based on the results of these studies, the responder rate in the EBV Study Treatment Group is expected to be approximately 35% at 1 year. The responder rate for the control group is not expected to exceed 10% at 1 year. Assuming a two-sided 0.05 alpha level, study power of 90%, and 2:1 allocation random assignment, a sample size of 147 will be adequate to test for superiority. The study sample size will be increased to 183 in order to allow for 20% lost to follow-up and incomplete data. Each study site will be allowed to enroll a maximum of 25 study participants.
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