5 results
Primary:The primary objective of the study is to demonstrate the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects undergoing spine, liver, vascular or soft tissue surgery, when…
The study will be performed in 3 parts, Parts 1, 2 , 3. and 4 (DDI). The purpose of the study is to investigate how safe the compound is and how well the compound is tolerated; this will be investigated in all study parts. In Parts 1 and 2, it will…
1. To characterize the efficacy of topical Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, in surgical subjects when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical2. To…
The primary objective of this trial is to investigate the safety of Fibrocaps* in subjects undergoing liver resection.The secondary objective of this study is to investigate the effectiveness of Fibrocaps* on time to achieve haemostasis and volume…
Primary Objective: To assess the safety profile (AEs, SAEs) on combined treatment with tamoxifen and testosterone.Secondary Objectives:• AR to ER ratio on baseline FES- and FDHT-PET imaging (assessed per lesion and per patient by quantitative…