20 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…
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).
The purpose of the investigation is to confirm the safety and efficacy of the InDx implant in treatment of CMC osteoarthritis.
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…
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 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 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…
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…
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…
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.
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…
The primary aim of this study is to gain more insight into the recovery of older hip fracture patients in the HOME group by continuously monitoring them with the MOX for six weeks.
The primary objective of the study is to assess the performance of the updated algorithm software. The secondary objectives are to assess the safety and other performance parameters of the updated software algorithm. Additionally, another secondary…
To investigate the feasibility of treating pediatric patients with suspected dysfunctional breathing with the Glimp Pebbles.
To test the hypothesis that paclitaxel-coated balloon treatment of vulnerable lipid-rich plaques leads to a greater reduction of the lipid-core burden index than guideline-directed medical therapy alone.
The primary objective of the study is to explain poor speech understanding at an individual level, with the ultimate goal of finding optimal personalized settings for the speech processor. We use the new measurement method of direct stimulation…
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…