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A prospective, multi-centre, repeated measures, traditional feasibility study investigating neural health correlates with outcomes and evaluating focused multipolar implementation in the Phoenix Research System for newly implanted adult cochlear implant recipients.

This traditional feasibility study intends to inform a future pivotal trial in the following two ways. Firstly, it aims to evaluate the potential of neural health metrics triggered by FMS, to predict the implant recipient*s auditory performance -…

Comparison Of reduced DAPT followed by P2Y12 inhibitor Monotherapy with Prasugrel vs stAndard Regimen in STEMI patients treated with OCT-guided vs aNgio-guided completE revascularization.

This study has been transitioned to CTIS with ID 2024-515883-30-00 check the CTIS register for the current data. The primary objective of this study is to prove noninferiority regarding safety and effectiveness of 30-45 day of DAPT followed by…

Transcatheter Aortic Valve Replacement
With the Medtronic Transcatheter Aortic Valve Replacement System
In Patients at Low Risk for Surgical Aortic Valve Replacement

Demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is non-inferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low…

Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and
Reduced Left Ventricular Function: The PROTECT IV Trial

The primary objective of the PROTECT IV Trial is to demonstrate the superiority of percutaneous coronary intervention (PCI) performed with Impella® mechanical circulatory support (MCS; Impella CP®, Impella CP® with SmartAssist® or Impella 2.5®…

MARS study- Mesh Augmented Reinforcement of Abdominal Wall Suture Line in Patients Undergoing Midline Laparotomy to limit the Rate of Incisional Hernia ( IH) Occurrence

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…

Prospective non-randomised post-market study collecting clinical data on safety and effectiveness of the remed*®-System

This study aims to assess the safety and efficacy of the remed*® system in adult patients with moderate to severe central sleep apnea in real life.

Feasibility of in vivo image-guided navigation during a robot-assisted prostatectomy

To test the feasibility of image-guided navigation during robot-assisted prostatectomy

Specturi Device - Feasibility study

Clinical feasibility of the urine collection device, indicated by staff and parents.

PeRcutaneous cOronary intervention of native Coronary arTery versus venous bypass graft in patients with prior cORonary artery bypass graft surgery - the PROCTOR trial

To compare the clinical and angiographic outcomes of a strategy of native vessel PCI with SVG PCI in patients with prior CABG presenting with SVG failure and a clinical indication for repeat revascularization, as determined by the local Heart Team.

Single use vs reusable catheters in intermittent CatheterizatiOn for treatment of urinary retention: a Multicenter, Prospective, RandomizEd controlled, non-inferiority trial (COMPaRE)

The main objective of this trial is to determine whether reusable catheters are not less efficient as single use catheters, measured by symptomatic UTIs. Secondary objectives are adverse events like hospital admissions due to UTIs, urethral damage/…

Evaluation of the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence. The SENS-U trial

To evaluate cost effectiviness of the SENS-U (continuous ultrasonic bladder monitoring) in urotherapy for children with functional daytime urinary incontinence.

The Novel Use of Transcutaneous Electrical Nerve Stimulation in Patients with Angina and Non-Obstructive Coronary Arteries; a Pilot Study

To evaluate the effect of transcutaneous electrical nerve stimulation (TENS) in patients with ANOCA on the change in the summary score of the Seattle Angina Questionnaire (SS SAQ) after 1 month treatment with TENS, compared to baseline.

Effectiveness of a personalized eCoach for cardiovascular risk management targeting primary prevention in general practice*

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…

Accuracy of synthetic CT-images based on MRI-images compared to conventional CT-images for shoulder osteoarthritis evaluation and surgical planning

The objectives are to determine the accuracy and reliability of sCT compared to conventional CT regarding (1) classification ofshoulder osteoarthritis morphology and (2) planning for the 3D-position of a compound used for shoulderreplacement…

A Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation to Evaluate the Safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) in premenopausal women with Abnormal Uterine Bleeding (AUB).

Primary ObjectiveTo evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS).Secondary Objectives1. To evaluate the change of menstrual blood loss (MBL).2. To evaluate the effect of MBL on the quality of life (…

VIRTUAL Trial

The primary objective of this study is:- to measure the effect of the VR program Reducept on the NRS pain score in patients with inflammatory arthritis with chronic pain despite low disease activity.The secondary objectives are:- to measure the…

Initial Safety and Performance of the CellFX® nsPFA* Cardiac Surgery System for the Treatment of Atrial Fibrillation

The primary objective of this feasibility study is to demonstrate the initial safety and effectiveness of the CellFX® nsPFA* Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more…

The effect of Suturing Techniques on aberrant wound recovery after Total Hip Arthroplasty

The primary objective is to investigate which of the four suturing techniques (Monocryl Smooth Suture, Vicryl Rapide Suture in combination with Indermil Skin Glue, Dermabond Prineo Skin Closure System, Stryker Zip Skin Closure) shows the least…

Prospective, Non-Randomised Clinical Trial to investigate the BeGraft Aortic Stent Graft System and the BeGraft Peripheral Stent Graft System treating Aorto-iliac Occlusive Disease with CERAB (Covered Endovascular Reconstruction of Aortic Bifurcation)

The objective of this clinical investigation is to evaluate the safety and performance of the BeGraft Aortic covered stent Graft System & the BeGraft Peripheral covered stent Graft System (Bentley Innomed, Hechingen, Germany) in CERAB…

Anastomotic Perfusion Measuring Device, a Pilot Trial

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).