Common use of Study Design Clause in Contracts

Study Design. ‌ This will be a multi-center prospective, randomized, controlled study with EBV treatment statistically evaluated using Intent-to-Treat (ITT) analyses. Random assignment will be conducted using an allocation ratio of 2:1; two study participants will be randomized to the EBV Treatment arm for every one participant randomized to the Control arm. A maximum of 183 patients with severe heterogeneous emphysema, who meet study entry criteria, consisting of screening eligibility criteria, baseline eligibility criteria, and procedure eligibility criteria, will be enrolled. Safety and effectiveness of BLVR using the Pulmonx EBV will be evaluated at 1 year. For study participants who have been treated with EBV, a secondary intervention such as valve removal, replacement, or adjustment, as described in this protocol, may be considered during the study follow-up. Long-term data will be collected annually through 5 years. Per the regulatory plan agreed to with FDA, 1 year of follow-up is required pre-approval and the remaining 4 years of follow-up will be conducted post-approval. The flow of study participants through the study protocol is shown in Appendix 1.