Clinical trials: Safety and Performance
Journey II BCS Total Knee System
Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.
- Trial name
- JIIPROMS (NCT03903731)
- Testing
- Total knee arthroplasty with Journey II BCS Total Knee System
- Where
- 5 sites in United States, Belgium and 1 more
- Volunteers
- 600 people
- Sponsor
- Smith & Nephew, Inc.
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.
Sleep Deprivation, Burnout, Professional
Cognitive Performance After a Night Shift in Internal Medicine Residents
A quasi-experimental design where internal medicine residents in a high complexity hospital were assessed after a 24-hour shift for cognitive impairment by a trained neurologist.
- Conditions
- Sleep Deprivation, Burnout, Professional, Cognition Disorders
- Trial name
- NCT04053556
- Where
- Argentina
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hospital Italiano de Buenos Aires
Tachyarrhythmias, Heart Failure
Safety and Clinical Performance of the Protecta ICD and CRT-D
The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic…
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00982397
- Testing
- Protecta VR-ICD, Protecta DR-ICD or CRT-D
- Where
- 122 sites in United States, Austria and 19 more
- Volunteers
- 2,770 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ichthyosis
Patient Study to Evaluate the Safety and Emollient Performance of Doublebase Once in the Treatment of Ichthyosis
28 Day Survey study in patients with Ichthyosis
- Trial name
- NCT07783165
- Testing
- Doublebase Once
- Volunteers
- 100 people
- Sponsor
- Dermal Laboratories Ltd
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
Fractures of the Long Bones, Vertically Stable Pelvic Fractures
Observational Study for the Evaluation of the Clinical Performance and Safety Profile of the GALAXY FIXATION™ System and Orthofix Implantable Devices: GALAXY Study
The GALAXY FIXATIONTM System and Orthofix implantable devices study intends to evaluate the clinical performance and safety profile of the study medical/investigational devices in the standard clinical practice.
- Conditions
- Fractures of the Long Bones, Vertically Stable Pelvic Fractures, Vertically Unstable Pelvic Fractures
- Trial name
- NCT06690437
- Testing
- Galaxy Fixation System and Orthofix implantable devices
- Where
- 3 sites in Italy
- Volunteers
- 3 people
- Sponsor
- Orthofix s.r.l.
Dental Caries
Post-Approval Clinical Study to Evaluate the Calcivis Caries Activity Imaging System
This is a prospective, multi-centre, post-approval clinical study to assess the safety and the performance of the Calcivis Caries Activity Imaging System in aiding the identification of active caries lesions on the occlusal…
- Trial name
- NCT02098304
- Testing
- Calcivis Caries Activity Imaging System
- Where
- 3 sites in United Kingdom
- Volunteers
- 42 people
- Sponsor
- Calcivis Ltd
Elective HFOV for Respiratory Failure in Neonates/Infants, Rescue HFOV in Neonates and/Infants With Refractory Respiratory Failure Under Conventional Therapy
Servo-n HFOV Study: Safety and Performance in Neonates and Infants
The purpose of this study is to evaluate the safety and performance of High-Frequency Oscillatory Ventilation (HFOV) modes of the Servo-n ventilator in neonates and infants, by using a prospective, observational, single-arm…
- Trial name
- NCT06114992
- Testing
- Servo-n HFOV modes
- Where
- 4 sites in France, Poland and 1 more
- Volunteers
- 83 people
- Sponsor
- Maquet Critical Care AB
Hearing Loss
The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents
This study is a post-market, multicentre, prospective, single arm investigation aimed to systematically collect safety and performance data on the Sentio system, when used as intended for adolescents (12-17 years inclusive).
- Trial name
- NCT06844071
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Oticon Medical
Glaucoma
Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
A retrospective, non-interventional, observational, multi-center, chart review study to be conducted in participants who underwent placement of the XEN 45 Gel Stent as a standalone procedure or in combination with…
- Trial name
- NCT03868254
- Testing
- XEN Group, Phacoemulsification
- Where
- United States
- Volunteers
- 174 people
- Sponsor
- Allergan
Distal Radius Fracture, Distal Ulna Fracture
PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System
The study is a single-center, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the DVR Plates.
- Conditions
- Distal Radius Fracture, Distal Ulna Fracture, Osteotomy
- Trial name
- NCT04653051
- Where
- United Kingdom
- Volunteers
- 111 people
- Sponsor
- Zimmer Biomet
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
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.
Sore-throat, Cough
The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up Study
Demulcent or soothing substance is the currently recommended option to alleviate throat irritation associated to cough and sore throat in children under 6 years.
- Trial name
- Touxpetit (NCT06688370)
- Testing
- Petit Drill
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Pierre Fabre Medicament
Hemorrhage, Surgical
Clinical Safety and Performance of GATT-Patch in Open Liver Surgery
The purpose of this study is to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery.
- Trial name
- NCT04819945
- Testing
- GATT-Patch
- Where
- 3 sites in Netherlands
- Volunteers
- 56 people
- Sponsor
- GATT Technologies BV
Patient Participation
Safety and Performance of Optivantage Multi-use When Injecting Contrast Media for Contrast Enhanced CT Examination
The study is a prospective, single-arm observational multicenter clinical investigation. The primary objective is to confirm the safety and performance of the Optivantage® Injection System when injecting contrast media to…
- Trial name
- NCT05537779
- Testing
- CT examination
- Volunteers
- 100 people
- Sponsor
- Guerbet
Common Warts, Plantar Warts
Salicylic Acid Wart Patch for the Treatment of Common Warts and Plantar Warts
Common and plantar warts are a type of skin lesion caused by infection with the human papilloma virus. The incidence of warts is relatively high, with an estimated few to several per cent of the adult population affected.
- Trial name
- NCT06958237
- Testing
- salicylic acid wart patches
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Langsteiner sp. z o.o.
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.
Mandible Fracture, Mandibular Reconstruction
Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up
A retrospective post market follow up to confirm safety and performance of Stryker's Surgeon iD Plates (SMRP) medical device. The study is performed to confirm the product's performance and safety by systematically collecting…
- Trial name
- SMRP (NCT07221916)
- Testing
- Mandibular Reconstruction
- Where
- 2 sites in United States, Germany
- Volunteers
- 70 people
- Sponsor
- Stryker Craniomaxillofacial