Clinical trials: Performance and Safety
Ankle Fractures, Knee Fractures
Performance and Safety Follow-up of Bioabsorbable Headless Inion CompressOnTM Screws in the Fixation of Bone Fractures in Ankle, Knee and Elbow of Pediatric and Adolescent Patients
The study in question is a post market clinical follow up (PMCF) study to follow up the safety and performance of bioabsorbable headless compression screw Inion CompressOn in fracture fixation of the ankle, knee and elbow of…
- Conditions
- Ankle Fractures, Knee Fractures, Elbow Fractures
- Trial name
- NCT07473947
- Testing
- Fracture fixation operation
- Where
- Finland
- Volunteers
- 80 people
- Sponsor
- Inion Oy
Chronic Functional Constipation
Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months
The study is aimed at the efficacy and safety evalutation of the study treatments through a 2-weeks study period and the subsequent follow-up-
- Trial name
- NCT02751411
- Testing
- micro-enema with Promelaxin, Macrogol 4000
- Where
- 4 sites in Italy
- Volunteers
- 158 people
- Sponsor
- Aboca Spa Societa' Agricola
Dental Caries, Insufficient Dental Filling
A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous Teeth
The overall aim of this clinical investigation is to assess the clinical performance and safety of composite restorations cured with fast curing mode (5 seconds with 2000 mW/cm²) in primary molars.
- Trial name
- NCT07212660
- Testing
- Fast curing mode, Conventional curing mode
- Where
- 2 sites in Switzerland
- Volunteers
- 70 people
- Sponsor
- Ivoclar Vivadent AG
Coronary Artery Stenosis
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family
The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.
- Trial name
- NCT05536180
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Arthesys
Hepatic Tumor
Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.
- Trial name
- NCT04230642
- Testing
- The Quantum Surgical device
- Where
- 2 sites in France
- Volunteers
- 22 people
- Sponsor
- Quantum Surgical
Dyslexia
Evaluation of the Performance and Safety of a Medical Device Developed to Improve the Reading of Dyslexic Patients
The aim of this study is to evaluate the efficacy and safety of a new medical device on the improvement of reading skills of dyslexic patients.
- Trial name
- DysLight (NCT04157829)
- Testing
- Scintilling lamp, Classic lamp
- Where
- 4 sites in France
- Volunteers
- 33 people
- Sponsor
- SATT Ouest Valorisation
Cerebral Palsy
Safety and Performance of Agilik in CP
The purpose of this post market study is to demonstrate the safety and performance of a powered extension assist (EA) knee ankle foot orthosis (KAFO), or EA-KAFO, in individuals with knee extension deficiency due to cerebral…
- Trial name
- Agilik (NCT05746871)
- Testing
- Agilik, standard care
- Where
- Italy
- Volunteers
- 9 people
- Sponsor
- IRCCS Eugenio Medea
Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia
Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
This prospective observational study will evaluate the safety and performance of the MiniLung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure.
- Conditions
- Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia, Acute Respiratory Failure, Acute Lung Injury
- Trial name
- PETIT (NCT06750536)
- Testing
- MiniLung petite kit combined with the Xenios console
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Xenios AG
Localized T1-T2 Prostate Cancer
SpaceOAR System RWS in China
This study aims to evaluate the safety and performance of SpaceOAR System when it is used to create space between the rectum and prostate in men undergoing radiotherapy for localized T1-T2 prostate cancer in China via collecting…
- Trial name
- NCT05407714
- Testing
- SpaceOAR Treatment
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Temporomandibular Joint Disorders
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
This is a long-term (10 years), retrospective-prospective, observational, single-arm, monocenter study of patients to be treated with the Materialise TMJ Total Arthroplasty System for TMJ replacement.
- Trial name
- NCT06951178
- Testing
- TMJ Total Arthroplasty System (TMJ System)
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- Materialise
Heart Defects, Congenital
Safety and Performance of a Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
Xeltis developed biodegradable patch prosthesis, the Vascular Patch Model COR-VP-001, to be used as a vascular patch to augment the pulmonary trunk and pulmonary arteries.
- Trial name
- XEL-CR-06 (NCT02377700)
- Testing
- Xeltis Vascular Patch, Model COR-VP-001
- Where
- Russia
- Volunteers
- 5 people
- Sponsor
- Xeltis
Diabetes (Insulin-requiring, Type 1 or Type 2)
Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS)
This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 system in people living with insulin-requiring diabetes in comparison with the…
- Trial name
- NEXUS (NCT07227805)
- Testing
- NMX8, 780G
- Where
- 9 sites in Belgium, Denmark and 2 more
- Volunteers
- 116 people
- Sponsor
- Medtronic MiniMed, Inc.
Type 1 Diabetes
Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.
A single arm, interventional study with 12 weeks study phase preceded by a 2-week run in phase, aiming to evaluate the effectiveness and applicability of the Tandem Mobi automated insulin delivery system (Tandem Mobi Pump System)…
- Trial name
- Captain MOBI (NCT06979635)
- Testing
- Tandem Mobi Hybrid Closed Loop (HCL) pump
- Where
- Israel
- Volunteers
- 12 people
- Sponsor
- Rabin Medical Center
Single-Port Colorectal Surgeries
A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Colorectal Surgeries（SPiM-RWS-CR）
A real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port robot-assisted colorectal surgeries in the real world, providing a real world…
- Trial name
- NCT06141421
- Testing
- procedure
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Ruijin Hospital
Diquat Poisoning
Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples
This is an observational, non-interventional diagnostic accuracy study designed to evaluate a diquat quantitative detection kit (ambient ionization mass spectrometry method) and a portable mass spectrometry analysis system for…
- Trial name
- NCT07399574
- Testing
- Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method)
- Where
- China
- Volunteers
- 60 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Abdominal Vascular Surgery, Peripheral Vascular Surgery
A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C
Purpose of the study is to describe safety and performance of POLYMAILLE® C from a minimum of 200 subjects will be evaluated. A minimum of 100 subjects will be evaluated for each main location of surgery (abdominal and…
- Conditions
- Abdominal Vascular Surgery, Peripheral Vascular Surgery, Vascular Prothesis, Aneurysm Abdominal
- Trial name
- NCT05517876
- Testing
- Vascular abdominal or peripheral surgery
- Where
- France
- Volunteers
- 212 people
- Sponsor
- Perouse Medical
Heart Defects, Congenital
Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection
The extracardiac Fontan surgery/procedure involves diverting the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle.
- Trial name
- EC-TCPC (NCT02377674)
- Testing
- Vascular Graft, Model COR-VG-001
- Where
- Russia
- Volunteers
- 5 people
- Sponsor
- Xeltis
Behavior
RxConnect User Testing Study
Background Medication errors are the leading cause of preventable harm in healthcare settings worldwide. An estimated 237 million medication errors occur in England alone every year, with 66 million considered clinically…
- Trial name
- NCT05493072
- Testing
- RxConnect
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Meniscus Tear
Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations
This study is a post-market follow-up study (PMCF). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for use (IFU) for meniscal repair…
- Trial name
- FAST-FIX FLEX (NCT04903106)
- Testing
- FAST-FIX FLEX Meniscal Repair System
- Where
- 5 sites in United States, Australia and 2 more
- Volunteers
- 63 people
- Sponsor
- Smith & Nephew, Inc.
NEC
Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird)
Preterm infants are highly vulnerable and may suffer from multiple life-threatening conditions that manifest low tissue oxygenation (StO2).
- Trial name
- (Songbird) (NCT05278247)
- Testing
- NIRS
- Volunteers
- 50 people
- Sponsor
- Carag AG