3 results
To provide idelalisib, a marketed PI3K* inhibitor, in lieu of GS-9820, an investigational second generation PI3K* inhibitor, to subjects receiving GS-9820 in Study GS-US-315-0102 at the time of study closure.
The primary objective of this study is to evaluate the effectiveness of two differently sized pistons used in primary stapedotomy for otosclerosis in terms of hearing improvement, complication rate and general and disease-specific quality of life.
To conform the procedural safety of the OSSURE LOEP Kit in the specific clinical setting of use in the femoral neck in patients with osteoporosis. Secondary objective: To evaluate the post-market clinical performance of the OSSURE LOEP Kit.