17 results
The purpose of this prospective, pivotal, multi-center, single-arm cohort, pre-market, investigational clinical study is to assess the safety and performance of Deternia* Self-Gripping Resorbable Mesh when used for suture line reinforcement after…
To investigate the effects of a 5-day diet with 30% caloric and 70% protein restriction on cardiotoxicity induced by anthracycline treatment in women with triple negative or hormone receptor-positive breast cancer. The biomarker high-sensitivity…
Determination of the (cost)effectiveness of the replacement of the expensive, risky and time-consuming food challenge test bythe Basophil Activation Test (BAT) for the diagnosis of an IgE-mediated cow*s milk allergy in children.
The aim of this study is to investigate the effect of two distalisation techniques of a gastric bypass in revisional surgery with standardised limb lengths in total weight loss (TWL) and the need for treatment for protein calorie malnutrition (PCM…
To examine the prevalence, risk factors and mechanisms of impaired health outcomes (short- and long-term medical and psychosocial effects and late effects) over time among a population-based sample of AYA cancer patients.Primary Objective: - To…
The aim of this study is to investigate the safety and efficacy of CAL-WR as primary and curative colon-preserving treatment for T1 colon cancer. Our primary endpoint is reduction of oncologic resections for low-risk T1 colon cancer. As secondary…
To evaluate RRS with delayed RRO as an alternative for RRSO in BRCA1/2 gene germline mutation carriers. We hypothesize that RRS with delayed RRO leads to an equal ovarian cancer incidence when compared to RRSO.
1. To identify the perceived barriers and facilitators for initiating and maintaining a healthy lifestyle in people with both DM2 and a low SEP. 2. To co-create a digital, personalised CBT lifestyle tool together with end users (people with DM2) to…
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 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 main objectives of this project are:- To start a prospective observational cohort study of patients who have been diagnosed with CRC, small bowel and anal cancer and follow them from time of diagnosis until death.- To prospectively collect data…
Our objective is to compare the efficacy of early chest tube removal combined with single-shot PVB versus standard treatment (chest tube for at least 3 days and thoracic epidural analgesia (TEA)) after surgery for PSP. Efficacy is defined as…
Primary Objective The primary objective of this study is to compare the 3-year overall survival of stage III NSCLC patients during follow-up surveillance with 18F FDG PET/CT versus follow-up with conventional CT surveillance. Secondary…
In this study we will compare a hybrid DEB strategy with a conventional bailout 2-stent strategy (TAP/T-stenting or Culotte) in patients with a bifurcation lesion with sub-optimal side-branch result. The primary endpoint will be the composite…
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…
Main objective is to assess the effectiveness of SP+ in an almost real-life setting of a randomised controlled trial (RCT) in 930 women with obesity, using CVMD-score as primary outcome measurement. Secondary aim is to assess the cost-effectiveness…
This study aims to determine the effect of real-time symptom monitoring on HRQoL in patients with mBC who start first-line chemo(immune)therapy. Further objectives include analyzing the effect of PRS monitoring on physical functioning, the severity…