3 results
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
Primary Objective: To answer the following question: Does the extended approach (defined as uroflowmetry and bladder scan after the first consultation, followed by a check-up in month 3 of the male patient over 50 years of age first presenting with…
7.1 Primary objectiveThe primary objective of the study is to assess the attitude towards the use of the MedRing 7.2 Secondary objectiveThe secondary objectives of the study are to assess device related adverse events, device damage and physician…