111 results
The objective of this study is to accumulate clinical data on the safety and performance of NBGM200 embolization in patients with degenerative OA of the knee refractory to conservative treatment so as to provide evidence of conformity with…
The primary objective of the study is to determine whether AVIM therapy in combination with medical therapy is more effective at reducing ambulatory systolic blood pressure (aSBP) and to determine whether AVIM therapy is safe.
The first part of the study aims to depict speech and swallowing function with 3D-dMRI in healthy volunteers to establish a set protocol for use in patients. The second part of the study will investigate if anatomical and functional differences in…
The primary objective of the study is to assess the feasibility and safety of sequential ETLA treatment in patients with severe emphysema with hyperinflation. The secondary objective of the study is to assess efficacy of sequential ETLA treatment…
The objective of this trial is to confirm that there are no new safety and performance outcomes for participants receiving the Axonics SNM System INS Model 4101 for the treatment of OAB and FI. The only notable difference between the existing,…
The objective of the SEAL Early Feasibility Study (STUDY) is to provide proof of concept and initialclinical safety data for the Aortoseal Endostapling System for the fixation and seal of abdominal aorticaneurysms (AAA) endovascular grafts to the…
Primary objective:To evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist Transport System.Secondary objective(s):The secondary objectives are to evaluate…
The main objective of the study is to optimize the use and user-friendliness of the voice analysis program, which could potentially help with the early detection of acute deterioration in heart failure. Hopefully, we can develop a technique that…
The primary objective of this study is to evaluate the efficacy of the AtMoves Knee System in the clinical diagnostic process of aseptic knee loosening in knee prostheses. This will be measured by the number of *failed outcomes* resulting from…
The primary objective of this study is to compare the mean binocular DCIVA at 66 cm under photopic conditions 3 months after cataract surgery, in a series of patients, who previously underwent myopic laser surgery, bilaterally…
The general aim of this project is to determine the (cost-)effectiveness of footwear modification in addition to GP-led usual care, compared to GP-led usual care alone for patients with first MTP joint osteoarthritis (OA) at 6 months of follow-up…
The ultimate objective is to optimize pessary treatment for all patients with pelvic organ prolapse (POP). To reach this goal, we need to learn more about the mechanisms behind success and failure of pessary treatment. Previous research suggested…
The primary objective of this study is to assess the safety and performance of the ABLE Daily to perform ambulatory functions in home and community settings for people with spinal cord injury.The secondary objectives are to assess the impact of the…
This study aims to assess the long-term impact of the POSE-2 procedure on weight loss, specifically focusing on the percentage of total weight loss (%TWL) over a 5-year follow-up period. Additionally, the durability and safety of the procedure will…
The objective of this study is to evaluate the effectiveness of the STIL orthosis in people with dystonic tremor. In addition, we will investigate participants' satisfaction with the STIL orthosis. The results of this study will provide…
The purpose of the pivotal study is to determine the safety and efficacy of IMPEDE-FX RapidFill for increasing the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label EVAR stent graft…
This study aims to compare outcomes between ring augmented RYGB (RaRYGB) using the MiniMizer and standard RYGB without a ring.
Primary objective: 1. To validate the data quality and diagnostic accuracy of StrokePointer to detect LVO stroke among patients with a suspected stroke in the pre-hospital setting. Secondary objectives:1. To determine the user-…
To assess the efficacy of the Tinnitus Implant System on tinnitus loudness in adults with moderate to severe chronic tinnitus accompanied by normal hearing to moderately severe hearing loss at 6 months post-activation of the Tinnitus Implant System…
A pilot study on digital coaching in rUTI at the Urology Department of Isala tested an app-based treatment additional to standard care.[8] The app provides information on rUTI aetiology, lifestyle recommendations, treatments, and the value of…