Clinical trials: Medical Devices
Urinary Incontinence, Medical Device Discomfort
Tolerance, Use and Performance of the PEASY Urine Collection Device in Hospitalized Patients
At present, 3 types of urine collection device can be distinguished: absorbent devices (diaper-type), penile clamps and penile collection sheaths.
- Trial name
- TUPELO (NCT07028996)
- Testing
- Daily use of the PEASY urine collection device for 5 days, Daily collection of patient feedback using a visual analog scale (0-100)
- Where
- France
- Volunteers
- 11 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Bone Diseases, Image
Clinical Validation of BoneMRI in the Spine
BoneMRI is a quantitative 3D MRI technique that has been developed recently by MRIGuidance BV©, which is based on a multiple gradient-echo sequence and a machine learning processing pipeline.
- Conditions
- Bone Diseases, Image, Medical Device
- Trial name
- CleverBones (NCT06745791)
- Testing
- BoneMRI
- Where
- 10 sites in Belgium, France and 2 more
- Volunteers
- 450 people
- Sponsor
- MRIguidance B.V.
Medical Device Related Pressure Ulcer (MDRPU), Pressure Injury
Clinical and Cost-Effectiveness of an Artificial Intelligence -Synthesized Nursing Care Bundle for Preventing Medical Device-Related Pressure Injuries
Medical device-related pressure injuries (MDRPIs) are an important and largely preventable patient safety problem, particularly in intensive care units where the use of medical devices is frequent and prolonged.
- Trial name
- NCT07789613
- Testing
- Control Group, Care Bundle Group
- Where
- Turkey (Türkiye)
- Volunteers
- 220 people
- Sponsor
- Koç University
Medical Device, Medical Device Performance
Clinical Evaluation of an Airborne Pathogen Containment Device: Randomized Open-label Equivalence Trial During Endotracheal Intubation
The aim of this study is to test a bubble-like dome (made of clear plastic) being placed over patients' heads during surgery as a tool to prevent the spread of germs through the air in hospitals.
- Conditions
- Medical Device, Medical Device Performance, Aerosol Generating Procedure
- Trial name
- NCT06968377
- Testing
- A novel airborne pathogen containment device.
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- IWK Health Centre
Medical Device Site Erosion
Nursing Interventions on Prevention Medical Device Related Pressure Injury (MDRPI)
This study aims to assess the effect of implementing nursing interventions on preventing medical device related pressure injury in critically ill patients.
- Trial name
- MDRPI (NCT06513936)
- Testing
- The skin care Bundle, Routine care
- Where
- Egypt
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Damanhour University
Oncology, Medical Devices
Capillary-Venous Paired Data Collection
Capillary-venous paired data collection.
- Conditions
- Oncology, Medical Devices, Healthy Subjects
- Trial name
- CaVeP-DC (NCT05926362)
- Where
- 2 sites in United Kingdom
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Entia Ltd
Cancer, Medical Device Performance
Capillary-Venous Paired Collection
This study is recruiting participants to donate 3 capillary blood samples to be tested on the investigational system and venous blood to be tested on a comparator system.
- Trial name
- CaVe (NCT06183151)
- Testing
- Entia Liberty System
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 400 people
- Sponsor
- Entia Ltd
Rejuvenation, Lifting Efficacy
Efficacy and Safety of a Novel Monopolar Radiofrequency Device for Mid and Lower Face Rejuvenation
The aim of this study is to evaluate the efficacy and safety of mid- and lower-face lifting and contouring treatments using the novel monopolar radiofrequency device, NeoSculpt.
- Conditions
- Rejuvenation, Lifting Efficacy, Medical Devices
- Trial name
- NCT07590843
- Testing
- NeoSculpt
- Where
- South Korea
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Seoul National University Bundang Hospital
Medical Device-Related Pressure Injury, Pressure Injury
ADDIE-Based Training Program for Nurses on Medical Device-Related Pressure Injuries
Medical device-related pressure injuries (MDRPIs) are a significant and increasing problem in clinical settings, particularly in intensive care units, adversely affecting patient outcomes and increasing healthcare costs.
- Conditions
- Medical Device-Related Pressure Injury, Pressure Injury, Nursing Education
- Trial name
- NCT07553026
- Testing
- ADDIE-Based Training Program
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people
- Sponsor
- University of Gaziantep
Instrumental Delivery, Medical Device
ASSIST Ethiopia: Feasibility Clinical Investigation of the Odonassist™ Medical Device
The Innovation The OdonAssist™ is a medical device for assisted vaginal delivery (AVD), that is defined by the need of additional procedure to facilitate childbirth in order to reduce foetal-maternal risks.
- Conditions
- Instrumental Delivery, Medical Device, Feasibility Study, Acceptability Study
- Trial name
- ASSISTEthiopia (NCT06918509)
- Testing
- OdonAssistTM
- Where
- Ethiopia
- Volunteers
- 20 people
- Sponsor
- Doctors with Africa - CUAMM
Medical Device-Related Pressure Injury, Prematurity
Non-Invasive Ventilation Interfaces and Nasal Pressure Injury in Preterm Infants
The goal of this randomized controlled clinical trial is to learn whether different non-invasive ventilation interfaces can prevent medical device-related nasal pressure injury in preterm infants receiving respiratory support in…
- Trial name
- NIV-MDRPI (NCT07521410)
- Testing
- Binasal Prong, Nasal Cannula, Nasal Mask
- Where
- Turkey (Türkiye)
- Volunteers
- 75 people
- Sponsor
- Istanbul University - Cerrahpasa
Medical Device-Related Pressure Injuries, Clinical Decision-Making
Operating Room Nurses' Knowledge of Medical Device-Related Pressure Injuries and Clinical Decision-Making Skills
This multicenter, scenario-based cross-sectional study aims to examine the effect of operating room nurses' knowledge of medical device-related pressure injuries on their clinical decision-making skills.
- Trial name
- OR-MDRPI-KnowD (NCT07527377)
- Testing
- None AHT
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- University of Gaziantep
EEG, Neonatology
An Observational Study of the NeuroBell EEG Monitor
An observational clinical investigation of the NeuroBell EEG Monitor (a portable and wireless EEG monitor).
- Conditions
- EEG, Neonatology, Seizure, Neurology
- Trial name
- NCT07508670
- Testing
- NeuroBell EEG Monitor
- Where
- Ireland
- Volunteers
- 17 people
- Sponsor
- University College Cork
Virtual Reality, Medical Device
Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.
The purpose of this study is to assess the effect on patient's comfort of a virtual reality experience during a procedure of cardiac electronic device implantation under local anesthesia.
- Conditions
- Virtual Reality, Medical Device, Local Anesthesia, Pain
- Trial name
- NCT06346132
- Testing
- Virtual reality application
- Where
- Switzerland
- Volunteers
- 150 people
- Sponsor
- Schlotterbeck Hervé
Multiple Sclerosis, Medical Device
Use of Inertial Units in Patient With Multiple Sclerosis (IMUSEP)
The goal of this case control study is to evaluate the use of inertial navigation systems to detect and characterize early locomotor disorders in patients with multiple sclerosis (MS).
- Conditions
- Multiple Sclerosis, Medical Device, Coordination and Balance Disturbances
- Trial name
- IMUSEP (NCT06634225)
- Testing
- Usual care (as recommended by the Haute Authorité de Santé (HAS)) and medical device test
- Where
- 2 sites in France
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Lille Catholic University
Breast Cancer, Medical Device
Smart Bra for Diagnosing Breast Cancer
This project aims to assess the ability of a portable and connected medical device to detect breast abnormalities, for breast cancer screening. It will accelerate technological progress in the face of breast cancer.
- Trial name
- CBRA (NCT05294016)
- Testing
- BRA CONNECT device
- Where
- 2 sites in France
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Hopital Nord Franche-Comte
Pressure Injuries, Medical Device Related Pressure Ulcer (MDRPU)
Effect of Central Venous Catheter Dressing Types on Device-Related Pressure Injuries
The purpose of this clinical trial is to evaluate the effect of different central venous catheter dressing methods on the development of medical device-related pressure injuries in participants treated in the intensive care unit.
- Trial name
- CVC PROTECT (NCT07437040)
- Testing
- Gauze Dressing, Chlorhexidine Gluconate Transparent Dressing
- Where
- Turkey (Türkiye)
- Volunteers
- 78 people
- Sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Children, Medical Device
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology
Interest of a Taurolidine lock at each catheter closure in the primary prevention of catheter-related endoluminal infection in paediatric oncology. Multicentric, controlled, randomized and double-blind label study.
- Conditions
- Children, Medical Device, Primary Prevention, Oncology
- Trial name
- PEDIALOCK (NCT05781295)
- Testing
- TaurolockTM, Physiological serum
- Where
- 5 sites in France
- Volunteers
- 148 people
- Sponsor
- Institut Curie
Ventilator Acquired Pneumonia, Central Line Associated Blood Stream Infections (CLABSI)
Evidence-Based Nursing to Reduce Adverse Events Regarding Ventilator Associated Pneumonia, Pressure Injuries and Central Line Bloodstream Infection in Intensive Care Unit in Bangladesh
Quality of care is crucial for preventing adverse events such as infection in the intensive care units (ICUs). The most common ICU-acquired infections include pneumonia such as Ventilator Associated Pneumonia (VAP), Pressure…
- Conditions
- Ventilator Acquired Pneumonia, Central Line Associated Blood Stream Infections (CLABSI), Pressure Ulcer (PU), Medical Device Related Pressure Ulcer (MDRPU)
- Trial name
- EBP in Nursing (NCT07299799)
- Testing
- Education with EBP, This is a pre- and post- quasi-experimental study.
- Where
- 2 sites in Bangladesh, Japan
- Volunteers
- 272 people, healthy volunteers welcome
- Sponsor
- Hiroshima University
Pressure Injuries, Pain
Adhesive Devices Versus Elastic Devices for Urinary Catheter Securement in Critically Ill Patients Experimental Study
Nowadays there are two types of urinary catheter securement devices, adhesive and elastic bands. The goal of this clinical trial is to determine which type of device-adhesive or elastic-is more effective for securing urinary…
- Conditions
- Pressure Injuries, Pain, Catheter-Associated Urinary Tract Infection, Medical Device Site Injury
- Trial name
- NCT07093437
- Testing
- GRIP-LOK FOLEY SECUREMENT DEVICE ®, CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETER
- Where
- Spain
- Volunteers
- 188 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau