4 results
Primary Objective:* To investigate the value of the Softscan in the early prediction of tumor response (RECIST criteria) to neoadjuvant chemotherapy or hormonal therapy in breast cancer. Secondary Objective:* To assess the accuracy of the Softscan…
The Galvani Splenic Neuromodulation System consists of a lead, rechargeable implantable pulse generator, external components and accessories. The system is designed to deliver electrical stimulation to the splenic NVB in patients with moderate to…
The purpose of this study is to compare the effectiveness of treatment Arm A and Arm B by measuring the event free survival (EFS) and pathological complete response (pCR). EFS is defined as the time from the first treatment dose that the patient…
Study GAL1039 (www.clinicaltrials.gov, NCT NL78487.000.21) is an Open Label study evaluating the safety, tolerability and effects of splenic nerve stimulation with Galvani's neuromodulation system. Since it is an Open Label study, the…