Clinical trials: sponsored by KU Leuven
Caries, Defective Restorations
Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities
This is a randomized-controlled clinical trial to investigate the success rate of two new tooth-colored restorative materials in class I and II cavities over 5 years according to FDI criteria scores (1, 2 and 3).
- Trial name
- NCT05748327
- Testing
- Alcasite restorative material, Bulk fill glass hybrid restorative material
- Where
- Belgium
- Volunteers
- 58 people
- Sponsor
- Ivoclar Vivadent AG
Diabetes Mellitus, Type 1
Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity
Investigator initiated, randomised, placebo-controlled, double-blind, multi-centre primary intervention study to assess whether daily administration of B.
- Trial name
- SINT1A (NCT04769037)
- Testing
- B. infantis
- Where
- 8 sites in Belgium, Germany and 3 more
- Volunteers
- 1,149 people, healthy volunteers welcome
- Sponsor
- Helmholtz Zentrum München
Cardiac Output Measurements, Healthy Subjects
An Exploratory Clinical Study Non-invasive Monitoring of Cardiac Outputs
Pulsify Medical aims at developing a sensor designed for the non-invasive, continuous and real-time monitoring of cardiac hemodynamics in patients at risk based on new transducer technology and artificial intelligence.
- Trial name
- NCT05734664
- Testing
- Pulsify sensor, State-of-the-art ultrasound equipment
- Where
- Belgium
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pulsify Medical
Peripheral Arterial Disease
Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent in the Superficial Femoral Artery
This is a Belgian prospective multicentre registry to evaluate safety and performance of the Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic lesions.
- Trial name
- BOSS (NCT01499342)
- Where
- 2 sites in Belgium
- Volunteers
- 435 people
- Sponsor
- be Medical
Heart Failure, Heart Failure NYHA Class II
Implementation and Cost-evaluation of a Smartphone-based Telemonitoring and Digital Support in Patients With HF
The BEDICARE-HF study aims to go further in the research on digital support. The objectives of this study are to demonstrate the feasibility, acceptability, adoption, sustainability and safety of a of a smartphone-based digital…
- Conditions
- Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- Trial name
- BEDICARE-HF (NCT05487365)
- Testing
- Comunicare Solutions Smartphone Application, Completing a quality of life (QOL)-questionnaire
- Where
- Belgium
- Volunteers
- 330 people
- Sponsor
- Comunicare Solutions SA
Cognitive Disorders
A Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects Including an Assessment of Receptor Occupancy and Food Effect
This is a First-in-Human, Randomized, Placebo-controlled, Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects including Receptor Occupancy Measurements after Single Dose of SDI-118 and an Assessment of Food…
- Trial name
- NCT05486195
- Testing
- SDI-118
- Where
- Belgium
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AbbVie
Heart Valve Disease
European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR
This is a prospective, non-randomized, single-arm, multicentre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where ESPOIR pulmonary valve (PV) is prescribed in the usual manner in…
- Trial name
- ESPOIR (NCT02035540)
- Testing
- Decellularized human valves
- Where
- 8 sites in Belgium, France and 6 more
- Volunteers
- 121 people
- Sponsor
- corlife
Absence Seizures, Absence Epilepsy
ECV - Epihunter Clinical Validation
The goal of this prospective study is to validate a wearable EEG seizure detection solution compared to video EEG. Subjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2…
- Trial name
- ECV (NCT04615442)
- Testing
- Epihunter
- Where
- 4 sites in United States, Belgium and 2 more
- Volunteers
- 102 people
- Sponsor
- Epihunter NV
Metabolic Syndrome, Gut Bacteria
Health Improvement Through Food and Lifestyle Intervention Based On Personalized Retail Advice
FLORA is a longitudinal intervention study with a randomized, parallel group design. Primary objective is to improve metabolic health through gut microbiota modulation by means of a retailer-driven personalized dietary…
- Conditions
- Metabolic Syndrome, Gut Bacteria, Personalized Nutrition
- Trial name
- FLORA (NCT04102891)
- Testing
- Microbiota modulation diet
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- SmartWithFood
Heart Valve Disease
Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")
Evaluation of decellularized human heart valves for aortic heart valve replacement in comparison to current valve substitutes. Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and…
- Trial name
- ARISE (NCT02527629)
- Testing
- Decellularized human heart valves
- Where
- 8 sites in Belgium, Germany and 5 more
- Volunteers
- 144 people
- Sponsor
- corlife
Heart Failure
BeneMACS Study:HeartMate 2 (HM2)Left Ventricular Assist Device (LVAD) Survival in Non Transplant Patients is Equal/Better Than Results in Medical Literature
Study Purpose The purpose of the BeneMACS Long-Term LVAD Study is to demonstrate that survival in non transplant patients implanted with the HeartMate II LVAD as destination therapy in Belgium and the Netherlands are equivalent…
- Trial name
- BeneMACs (NCT00983190)
- Testing
- Left Ventricular Assist Device (HeartMate II)
- Where
- 2 sites in Belgium
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
Healthy
The Effects of Ashwagandha in Endurance Exercise Performance
Ashwagandha (Withania Somnifera) is a widely used herb in Ayurvedic medicine for vitality and rejuvenation. This study investigates the effects of both acute and short-term oral supplementation of Shoden (Ashwagandha extract)…
- Trial name
- NCT03596307
- Testing
- Ashwagandha extract
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Arjuna Natural Limited
Metastatic Colorectal Cancer, mCRC
LifePearl-Iri Pharmacokinetic Study
The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of LifePearl microspheres loaded with irinotecan in the treatment of liver predominant mCRC by chemoembolization.
- Trial name
- NCT02547480
- Testing
- TACE with irinotecan loaded LifePearl
- Where
- 3 sites in Belgium, Germany
- Volunteers
- 15 people
- Sponsor
- Terumo Europe N.V.
Acute Myocardial Infarction
Safety and Efficacy Evaluation of Intracoronary Infusion of Allogeneic Human Cardiac Stem Cells in Patients With AMI
Development of myocardial reparative therapy for the treatment of acute ischemic cardiac disease, based on the intracoronary administration of allogeneic Cardiac Stem Cells (CSCs) to ameliorate myocardial cell death and promote…
- Trial name
- CAREMI (NCT02439398)
- Testing
- Allogeneic human cardiac stem cells (CSCs), Human Serum Albumin-HSA 5%
- Where
- Spain
- Volunteers
- 55 people
- Sponsor
- Coretherapix
Melanoma
Proof of Concept Study With an Endothelin Receptor B Inhibitor (BQ-788) for Human Melanoma
Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788) or vehicle was preformed in 5 melanoma patients to have a preliminary analysis of safety, dose, duration and relevance of results observed in pre-clinical…
- Trial name
- NCT02442466
- Testing
- Endothelin Receptor B inhibitor BQ788, PBS
- Volunteers
- 5 people
- Sponsor
- MelCure SA