21 results
Part A: Determine the performance of using 4D DCE-BCT for tumour staging. Part B: Determine the performance of 4D DCE-BCT in monitoring of treatment response and prediction of final treatment outcome based on early response in patients that undergo…
The purpose of the investigation is to confirm the safety and efficacy of the InDx implant in treatment of CMC osteoarthritis.
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 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…
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 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 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 objective of the study is to evaluate the benefit of the eCoach in the general practitioner*s office within cardiovascular risk management. Specifically, the eCoach evaluates the effect on individual risk factors and the risk on developing…
We want to show in the current pilot trial that the current market ready automated device is safe and effective to use in humans as the proof of principle prototype, as well as check the instructions for use (IFU).
Primary: Can the AI pain assistant accurately inquire about postoperative pain (NRS) and all its dimensions, including location, type of pain, and any aggravation with movement? Secondary: review by a healthcare professional (quality and…
The primary objective of this study is to evaluate the adherence to a 3-month gamification intervention integrated with a recently developed platform for continuous lifestyle monitoring (Care-On) in patients with recurrent atrial…
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 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 objective is to investigate if AHCL in children with DM1 leads to a greater difference in BMI SDS compared to MDI. The second objective is to study if there is a difference between MDI and AHCL in DM1 regarding blood glucose regulation and…
The purpose of this study is to determine whether a NightWatch worn on the leg detects the same seizures as a NightWatch worn on the arm. In addition, the signal quality of both devices will be examined.
The aim of the PISCES study is to evaluate the long-term effectiveness of SCS by comparing a paresthesia-free form of stimulation that the patient does not feel, with sham stimulation in which no stimulation is given. The study will focus on…
Primary Objectives: The primary objectives of this study are: To validate the performance of the Steady Hands software as a medical device in assessing hand tremor symptom intensity for Parkinson’s Disease (PD) and Essential Tremor (ET) by…
This study aims to compare outcomes between ring augmented RYGB (RaRYGB) using the MiniMizer and standard RYGB without a ring.
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…