34 results
The objective of this clinical study is to assess the safety and effectiveness of the Apollo Intravascular Lithotripsy (IVL) System for lithotripsy-enhanced balloon dilatation of calcified, stenotic de novo coronary lesions prior to stenting.The…
The VOLT AF First-in-Human (FIH) study will collect feasibility data to show that the Volt PFA System functions as intended in a clinical setting and to demonstrate acute safety and effectiveness for the treatment of symptomatic, recurrent…
To assess the safety of a novel care pathway in which patients, with a predicted mild course of acute pancreatitis, are discharged early with remote home monitoring.
The purpose of this study is the evaluation of InPen* with InPen* 2.0 app and Guardian* 4 system in adult patients with type 1 diabetes for the design of a future study.
To collect safety and efficacy data from study participants that have been treated with the miraDry System using High Volume Anesthesia (HVA, also known as LTA or Local Tumescent Anesthesia) method as the local anesthesia delivery method.
The aim of the proposed study is to describe in older adults the incidence of respiratory viral infections and to gain better insight into the nasal mucosa and mucosal and systemic immune responses in older adults in the absence and presence of a…
This study is performed to investigate the optimal strategy for maintaining quality of life and improving survival in elderly patients (65 years or older) diagnosed with primary GBM. Primary endpoints of the study are: 1) Proportion of patients with…
The primary study objective is to evaluate the correlation of the calculated portosystemic pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with the EchoTip® systemic Pressure Gradient (EchoTip® InsightTM) and…
Determine the safety (oncological outcome and toxicity) of an comprehensive treatment combining recent advances in the treatment of high risk prostate cancer.
The primary objective of this study is to collect blood samples (maximum of 150 mL per study visit ) from women and men who have SLE and from volunteers in good health to study the immune system of SLE patients and to investigate new potential…
The objective of this study is to investigate whether an interatrial shunt device is superior to sham procedure in prevention of: (1) incidence of and time to cardiovascular mortality through 12-24 months; (2) incidence of and time to heart…
Collect clinical data in order to confirm the clinical safety and performance of the Pamira lead when used in routine clinical practice to support the regulatory post-market strategy in Europe and other regions and validation of promotional claims…
The primary objective of the registry is:To analyse coronary artery disease progression with or without coronary artery bypass grafting.The secondary objective of the registry is:To report graft patency following bypass grafting of diffusely…
The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation (PersAF).
To evaluate Hex4 concentrations in CSF from patients with infantile-onset (IOPD) and late-onset (LOPD) Pompe disease
The primary outcome parameter is the Gout Activity Score (GAS)after 6 months of rasburicase treatment. Secondary outcome parameters are the serum uric acid concentration, the clinical evaluation of tophus load, patient reported outcomes: MD-HAQ, GAQ…
Considering the paucity and the variability of data regarding the clinical control of infection in patients presenting a prosthesis Joint Infection (PJI) later than 1 month after the arthroplasty and treated with DAIR + suppressive antibiotics…
Primary Objective:- To assess and describe Quality of Life throughout a patients treatment trajectorySecondary Objective(s):- To assess and describe how frail unselected real world AML patients are at diagnosis using geriatric screening tools (G8, 6…
The objective of the HORIZON trial is to demonstrate and provide long-term clinical data on safety and performance of the Qmedics EXIST NiTi Stent System type FLEX & PULL for treating de novo or re-stenotic symptomatic atherosclerotic…
(also see: C1. Protocol, page 9, paragraph 2)Primary: Creating a metabolic bio-database with body material of patients with inherited metabolic diseases, combined with clinical data.Secondary: Achieve better participation in national and…