5 results
Primary objective:To determine target lesions tumour response.Secondary objectives:* To determine overall tumour response.* To determine the liver specific progression-free survival.* To determine non-liver specific progression-free survival.* To…
(1) Establishing normal values (cut-offs) for bipolar and unipolar voltage mapping during sinus rhythm and pacing. (2) Establish normal values for conduction velocity during sinus rhythm of the 4 chambers. (3) Establish normal values for activation…
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…
Primary objective:To establish the safety and toxicity profile of 166Ho-RE in patients with hepatocellular carcinoma. Secondary objectives:* To evaluate efficacy of 166Ho-RE in hepatocellular carcinoma without curative treatment options in a non-…
Primary objectives:* To evaluate efficacy of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate in a non-comparative phase II study Secondary objectives:* To establish the safety and toxicity profile of adjuvant 166Ho-RE after…