Clinical trials: Performance and Safety
Long Term Safety of the AMS 1.0
PROGRESS-AMS 1.0 Clinical Long Term Follow-Up
The primary objective of this study is to collect long term clinical follow-up data on all patients enrolled in the PROGRESS AMS-1.0 study to assess long term safety of the AMS-1.0
- Trial name
- NCT01610102
- Where
- 6 sites in Australia, Belgium and 3 more
- Volunteers
- 55 people
- Sponsor
- Biotronik AG
Transfusion Reaction
Clinical Performance Study of Safety Test ABO Device
The study aims to confirm the performance equivalence of the in vitro diagnostic device Safety Test ABO with the ABTest Card device.
- Trial name
- NCT06543771
- Testing
- Safety Test ABO and ABTest Card®
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Diagast
Bowel Dysfunction
An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents
The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents.
- Trial name
- NCT06385249
- Testing
- Navina Mini
- Where
- Sweden
- Volunteers
- 27 people
- Sponsor
- Wellspect HealthCare
Cervical Disc Disease, Degenerative Disc Disease
Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc in subjects who were enrolled in the post approval study (NCT04630626).
- Trial name
- NCT05258435
- Testing
- NuVasive Simplify Cervical Artificial Disc
- Where
- 10 sites in United States
- Volunteers
- 131 people
- Sponsor
- NuVasive
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
Bone Marrow Examination, Urologic Surgical Procedures
Comparison of the Clinical Performance and Safety of the Ambu®AuraGainTM Laryngeal Mask in Children Undergoing Surgery in the Supine and Prone Position - A Prospective, Noninferiority Clinical Trial
The Ambu Auragain is a 2nd generation laryngeal mask airway that is widely used in adult and pedicatric patients. While its use is generally recommended in patients undergoing surgery in the supine position, depending on patient…
- Conditions
- Bone Marrow Examination, Urologic Surgical Procedures, Orthopedic Surgery
- Trial name
- NCT05286021
- Where
- South Korea
- Volunteers
- 126 people
- Sponsor
- Yonsei University
Aortic Stenosis, Aortic Insufficiency
JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
- Conditions
- Aortic Stenosis, Aortic Insufficiency, Aortic Regurgitation
- Trial name
- JUPITER (NCT01598844)
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in Germany, Netherlands and 2 more
- Volunteers
- 210 people
- Sponsor
- JenaValve Technology, Inc.
Refractive Ametropia
A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
13 weeks, open-label, daily disposable contact lens dispensing study.
- Trial name
- NCT07322211
- Testing
- Treatment
- Where
- 2 sites in Taiwan
- Volunteers
- 35 people
- Sponsor
- Unicon Optical Co. Ltd.
Breast Implant Revision
LTFU of PCL Breast Scaffolds Used in 2021-BRV-004
The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with…
- Trial name
- NCT07383012
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
Surgery, Orthognathic Surgery
Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming.
- Conditions
- Surgery, Orthognathic Surgery, Orthognathic Surgical Procedures
- Trial name
- NCT05073757
- Testing
- Custom-made guides and plates
- Where
- 4 sites in Belgium, France
- Volunteers
- 56 people
- Sponsor
- Global D
Atrial Septal Defect, Patent Foramen Ovale
Post Market Registry of the CBSO
Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD)…
- Trial name
- CBSO Registry (NCT04105595)
- Testing
- Septal defect closure
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- atHeart Medical
Intracranial Aneurysm, Brain Arterial Disease
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.
- Conditions
- Intracranial Aneurysm, Brain Arterial Disease, Acute Ischemic Stroke, Peripheral Vascular Diseases
- Trial name
- EVIDENCE (NCT04927156)
- Testing
- BALT medical devices
- Where
- 12 sites in France, Germany and 1 more
- Volunteers
- 10,000 people
- Sponsor
- Balt Extrusion
Deformity, Defect, Congenital
Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb
Orthofix Srl put the JPS on the European market (2019) by the mean of a pre-market clinical evaluation made under the Medical Device Directive (MDD) requirements that were based on the analysis of the scientific literature of…
- Conditions
- Deformity, Defect, Congenital, Trauma
- Trial name
- JPS (NCT05245617)
- Testing
- JuniOrtho™ Plating System™
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Orthofix s.r.l.
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
Performance and Safety of an Airway Management Device
Comparison of the BASKA Airway, a Novel Supraglottic Device, to the LMA Airway in Low Risk Female Patients
The investigators have performed a number of studies on novel airway devices, including an observational study on the performance of a new supraglottic airway named Baska mask.
- Trial name
- NCT01482650
- Testing
- supraglottic airway placement and use
- Where
- Ireland
- Volunteers
- 92 people
- Sponsor
- University College Hospital Galway
Mortality, Outcome
Checklist Application and Mortality
The study investigates the impact of the implementation of a surgical checklist on the mortality 30 days and 90 days after surgery.
- Trial name
- NCT01356446
- Testing
- implementation surgical checklist
- Where
- Italy
- Sponsor
- Regional Hospital of Bolzano
Aortic Valve Stenosis
REPRISE EDGE 29 mm EU Study
The objective of the REPRISE EDGE 29 mm EU study is to evaluate performance and safety of the 29 mm LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native…
- Trial name
- NCT02964962
- Testing
- 29 mm LOTUS Edge™ Valve System
- Sponsor
- Boston Scientific Corporation
Otitis Externa
Performance and Safety of Otinova® Ear Spray
The purpose of this study is to assess the performance and safety of Otinova® Ear Spray when used in the treatment of external otitis symptoms.
- Trial name
- NCT05370209
- Testing
- Otinova® Ear Spray
- Where
- 3 sites in Sweden
- Volunteers
- 28 people
- Sponsor
- Circius Pharma AB
Endodontically Treated Teeth
Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications
In this observational, retro-prospective, and multicenter PMCF clinical investigation, Biodentine™, an active dentine substitute for professional dental use only, is evaluated at 10 years post-treatment, in its endodontic…
- Trial name
- NCT05084742
- Testing
- Biodentine™
- Where
- 6 sites in France
- Volunteers
- 145 people
- Sponsor
- Septodont
Pulmonary Artery Stenosis
BeGrow Study to Treat Pulmonary Artery (PA) Stenosis in Newborns and Infants
Objective of the study is to assess safety and performance of the BeGrow Stent System for newborns and infants in pulmonary artery stenosis.
- Trial name
- NCT03287024
- Testing
- BeGrow Stent System
- Where
- 3 sites in Austria, Serbia and 1 more
- Volunteers
- 18 people
- Sponsor
- Bentley InnoMed GmbH