5 results
This non-controlled multicentric phase II study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase for first-line treatment of infants (< 1 year of age at…
The primary safety objective of this investigation is to assess the safety of long-term LES electrical stimulation therapy in patients with GERD.The primary functionality objective of this study is to evaluate the ability of the device to initiate…
This multicentre phase III study is designed to assess the efficacy and safety of recombinant versus E-Coli derived Aaparaginase from Medac, during treatment of children with newly diagnosed ALL according to the DCOG ALL-10 protocol.Futhermore: To…
To perform a pre-study to assess the feasibility of DE-MRI to assess lesion size, transmurality and completeness of pulmonary vein isolation. The study will be performed to determine if and how DE-MRI can be used in a larger subsequent multicentre…
To evaluate the safety and efficacy of long term stimulation of the lower esophageal sphincter in patients with gastroesophageal reflux disease after sleeve gastrectomy.