Clinical trials: Medical Device Performance
Infertility
Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle
This is a multicenter, prospective randomized controlled, interventional investigation to assess the safety and clinical performance of Forielle, a medical device for endometrial washing, in restoring favorable endometrial…
- Trial name
- ENDOMEDE (NCT03387059)
- Testing
- Forielle
- Where
- 7 sites in Italy
- Volunteers
- 9 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Diabetes Mellitus
Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device and Evaluation of the Instructions for Use
The aim of the study is to demonstrate the safety and performance of a novel non-invasive glucose monitoring device, to collect data and reference measurements for establishment of calibration models and to evaluate the…
- Trial name
- NCT04033042
- Testing
- Prototype 0.5
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- RSP Systems A/S
RDS of Prematurity, Preterm Birth
Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Pivotal study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Trial name
- NCT07060911
- Testing
- Lung monitoring with the Neola device
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Neola Medical Inc
Wounds
Simplified Negative Pressure Wound Therapy
The objective of this study is to implement a simplified Negative Pressure Wound Therapy (sNPWT) device in a low resource setting.
- Trial name
- NCT01339429
- Testing
- simplified negative pressure wound therapy device (Wound Pump device)
- Where
- 2 sites in Rwanda
- Volunteers
- 41 people
- Sponsor
- Brigham and Women's Hospital
Preterm Birth
Comparison of Non-nutritive Suck (NNS) Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants
This is a research study to quantitatively assess the development of non-nutritive suck (NNS) and feeding readiness in preterm infants using a novel device, the NTrainer©, and to compare this with two clinical assessment tools…
- Trial name
- NCT01069731
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- KC BioMediX, Inc
Scoliosis
Study of the Surgical Treatment of Early Onset Scoliosis Using a Non-invasive Growing Rod
It is current practice for children who have surgery for early onset scoliosis (EOS) to be treated with insertion of extendable implants known as growth rod systems.
- Trial name
- NCT01362881
- Where
- 2 sites in United Kingdom
- Volunteers
- 14 people
- Sponsor
- Ellipse Technologies, Inc.
Covid19, RSV Infection
Sample Collection Study to Aid Evaluation of an Influenza A/B, Respiratory Syncytial Virus & COVID-19 Virus POC Test
Collection of Nasal Swabs, Throat Swabs and Saliva Samples from patients presenting at their designated care or testing facility displaying symptoms of either Influenza, Respiratory Syncytial Virus (RSV), SARS-CoV-2 or those who…
- Conditions
- Covid19, RSV Infection, Influenza Type A, Influenza Type B
- Trial name
- INFORM (NCT04782336)
- Testing
- Sample Collection
- Where
- 6 sites in United Kingdom
- Volunteers
- 79 people
- Sponsor
- LumiraDx UK Limited
Hepatolenticular Degeneration; Wilson
Performance and Safety of MEX-CD1 Low-volume Continuous Veno-venous Haemodialysis Medical Device for Copper-extraction in Patients With Wilson's Disease
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from Wilson's Disease. The main questions it aims to answer are: Does the device work as expected by removing the excess of…
- Trial name
- MEXWILS (NCT05917327)
- Testing
- Low-volume continuous veno-venous haemodialysis
- Where
- 4 sites in France, Spain
- Volunteers
- 1 people
- Sponsor
- Mexbrain
Binocular Vision Disorder, Binocular Eye Movement Disorder
Performance and Safety Evaluation of the S360 Medical Device Software.
The aim of this interventional, cross-sectional study is to evaluate the performance and the safety of the medical device software S360.
- Conditions
- Binocular Vision Disorder, Binocular Eye Movement Disorder, Ocular Motion; Disorder
- Trial name
- ArgoS360 (NCT05522595)
- Testing
- S360
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Sierra Neurovision
Vascular Access Device
A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices
The objective of Teleflex's Vascular Access Device Registry (VADER) is to provide high-quality data on the performance, safety, and clinical benefits of Teleflex's vascular access devices when used in a real-world setting
- Trial name
- VADER (NCT06604039)
- Testing
- Central venous catheter
- Where
- 3 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Teleflex
Port a Cath
Structured Training on Oncology Nurses' Performance Related Port A Cath Device
evaluate the effect of structured simulation-based training on oncology nurses' performance regarding port A cath device.
- Trial name
- NCT05774301
- Testing
- simulation-based training
- Where
- Egypt
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Mansoura University
Stoma Ileostomy
Performance and Safety Evaluation of the SenSura® Mio Baby Device in Subjects With a Stoma
The aim of the non-interventional Post Market Clinical Follow-up (PMCF) study is to follow performance and safety of the newly marketed SenSura® Mio Baby device in a real-life setting.
- Trial name
- NCT03929978
- Volunteers
- healthy volunteers welcome
- Sponsor
- Coloplast A/S
Orthognathic Surgery, Maxillofacial Abnormalities
Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK®) used for…
- Conditions
- Orthognathic Surgery, Maxillofacial Abnormalities, Maxilla Fracture
- Trial name
- CMF-ORTHO (NCT05271383)
- Testing
- Orthognathic surgery using Global D's implants.
- Where
- France
- Volunteers
- 198 people
- Sponsor
- Global D
Performance and Safety of an Airway Management Device
Comparison of the Baska Mask Airway to a Single-use LMA Device in Low-risk Female Patients
The purpose of this study is to compare the performance of the Baska mask supraglottic airway device with a single use laryngeal mask device (LMA) in low-risk female patients.
- Trial name
- NCT01753635
- Testing
- supraglottic airway placement and use
- Where
- Ireland
- Volunteers
- 150 people
- Sponsor
- John Laffey
Infection, Bacterial
Clinical Performance Evaluation of AI-Enabled Automated Gram Staining Device
The investigators have developed an analysis AI for Gram staining. In this study, the investigators will compare the testing accuracy of automated Gram staining equipment with AI with the testing accuracy of laboratory…
- Trial name
- NCT06143657
- Testing
- Automated Gram Staining Machine analysis
- Volunteers
- 1,600 people
- Sponsor
- GramEye
Limb Length Discrepancy
Post-Market Study of the Ellipse PRECICE Intramedullary Limb Lengthening System
The purpose of this study is to obtain post market performance and safety data of the Ellipse PRECICE Intramedullary Limb Lengthening System for subjects undergoing unilateral limb lengthening.
- Trial name
- PINS (NCT01601301)
- Testing
- PRECICE System
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- Ellipse Technologies, Inc.
Gait Impairment, Cerebral Palsy (CP)
Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting
The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program…
- Conditions
- Gait Impairment, Cerebral Palsy (CP), Neuromuscular Diseases (NMD), Spinal Cord Injuries (SCI)
- Trial name
- NCT07745712
- Testing
- ABLE Kids
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- ABLE Human Motion S.L.
Contraception
Impact and Performance of Institutionalizing Immediate Post-partum IUD Services
Studying the impact and performance of institutionalizing immediate post-partum IUD services as a routine part of antenatal counselling and delivery room services in Sri Lanka, Tanzania, and Nepal.
- Trial name
- NCT02718222
- Testing
- Post-partum IUD
- Where
- 3 sites in Nepal, Sri Lanka and 1 more
- Volunteers
- 140,258 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Hypertension
A Multi-centre Study Evaluating the Performance and Acceptance of the Hilo Band Cuffless Blood Pressure Medical Device in the Normo-, Hypo- and Hyper-tensive Young Population: a Comparison With the 24-h Ambulatory Blood Pressure Monitoring (ABPM)
Hypertension is one of the main risk factors for the onset of cardiovascular diseases. It is often silent, and most individuals are unaware they have it.
- Trial name
- IPSI-HYPE-001 (NCT07072689)
- Where
- 2 sites in Switzerland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Simonetti Giacomo
Long-term and Permanent Contraceptive Methods
A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar
This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar.
- Trial name
- NCT01200576
- Where
- Madagascar
- Volunteers
- 621 people, healthy volunteers welcome
- Sponsor
- FHI 360