4 results
Primary clinical investigation objectives[Safety]The primary safety objective of the clinical investigation is to provide data that demonstrates safety of the device, defined as < 8.3% serious adverse device effects, up to 6 weeks following…
To assess the efficacy of treatment with monochloroacetic compared to treatment with cryotherapy regarding patients with handwarts and compared to combination therapy (salicylic acid and cryotherapy) regarding patients with plantar warts.WARTS-1 has…
The primary objective of this study is to evaluate the efficacy of SCH 503034800 mg TID PO in combination with PegIntron 1.5 *g/kg QW SC plus ribavirin (800 - 1400 mg/day) in previously untreated adult chronic hepatitis C (CHC) subjects infected…
Primary Safety Objective : To evaluate one month procedural and device safety of the Tendyne Bioprosthetic Mitral Valve System.Primary Safety Endpoint : Device success and freedom from the following device- or procedure-related serious adverse…