Clinical trials: Safety and Performance
Non-muscle Invasive Bladder Cancer (NMIBC)
Evaluating the Safety and Performance of the Eight Medical Hyperthermia System IV 1.0 for HIVEC in NMIBC.
The goal of this clinical trial is to evaluate the safety and performance of the Eight Medical Hyperthermia System IV 1.0 when used to deliver recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC) in…
- Trial name
- NCT07758881
- Testing
- Hyperthermic intravesical chemotherapy (HIVEC)
- Where
- 2 sites in Belgium
- Volunteers
- 30 people
- Sponsor
- Eight Medical International BV
Knee Osteoarthritis
Combination of PRP and XLHA Prepared With RegenMatrix Medical Device To Treat Moderate to Severe Knee Osteoarthritis
In this clinical trial the investigator assess the safety and efficacy of a single injection of a combination of cross-linked hyaluronic acid (HA) with autologous platelet-rich plasma (PRP) obtained with the RegenMatrix medical…
- Trial name
- NCT05727371
- Testing
- Regen Matrix-PRP-XLHA, Hylan G-F 20
- Where
- 13 sites in France
- Volunteers
- 280 people
- Sponsor
- RegenLab France SAS
Aortic Valve Disease
PILot Aortic Triflo Valve Study
A prospective, single arm, exploratory clinical investigation to assess preliminary safety and collect performance and effectiveness data of the TRIFLO Heart Valve.
- Trial name
- PILATUS (NCT06119607)
- Testing
- TRIFLO Heart Valve
- Where
- Lithuania
- Volunteers
- 10 people
- Sponsor
- Novostia SA
Intracranial Aneurysm
Neuroform Atlas Stent for Intracranial Aneurysm Treatment
The primary objective of this study is to demonstrate effectiveness and safety of the NeuroForm Atlas stent system for use in patients requiring stent assisted intracranial aneurysm treatment.
- Trial name
- ATLAS EU PMCF (NCT02783339)
- Where
- 11 sites in France, Germany and 1 more
- Volunteers
- 105 people
- Sponsor
- Stryker Neurovascular
Cataract, Vitrectomy
Clinical Study to Confirm the Safety and Performance of the Virtuoso Phaco-vitrectomy Device
This is a pre-market clinical investigation with a device that does not bear the CE-marking. Aim of the study is to confirm the safety and performance of the device and collect user feedback.
- Conditions
- Cataract, Vitrectomy, Vitrectomy Operation Under General Anesthesia
- Trial name
- Virtuoso1 (NCT06799156)
- Where
- Germany
- Volunteers
- 205 people
- Sponsor
- Beaver-Visitec International, Inc.
Elevated Intraocular Pressure (IOP)
Clinical Investigation of Eye C Better's Photobionic Intraocular Pressure Biomonitor Tonometer
The device being studied in this research is the investigational PIB, a tool designed to measure eye pressure without touching the eye.
- Trial name
- PIB (NCT07762053)
- Testing
- Photobionic IOP Tonometer (PIB)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- EyeCBetter Corporation
Jawline Contour Deficit
A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria® Intense Strong
A post-market Follow up clinical investigation to confirm the clinical safety and performance profile of Decoria®Intense Strong for the correction and improvement of jawline profile.
- Trial name
- DAG-ISJ (NCT06562075)
- Testing
- Decoria Intense Strong
- Where
- 7 sites in Sweden
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Bohus Biotech AB
Breast Reconstruction Following Mastectomy
Safety and Clinical Performance of a Biological Matrix Used in Implant-based Breast Reconstruction
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Breast membranes used in breast reconstruction and to identify emerging risks in comparison to clinical data…
- Trial name
- NCT05031962
- Testing
- CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)
- Where
- 10 sites in France
- Volunteers
- 112 people
- Sponsor
- Meccellis Biotech
Respiratory Insufficiency in Children
Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU
This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product. The purpose of the study is to demonstrate, in a routine clinical environment across a number of centers, that the fabian-PRICO…
- Trial name
- NCT04957472
- Testing
- fabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function, Manual Control
- Where
- 5 sites in Netherlands, Poland
- Volunteers
- 47 people
- Sponsor
- Vyaire Medical
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
Skin Hydration, Skin Elasticity
Efficacy and Safety of PN+HA (NEWEST) for the Improvement of Skin Hydration
This is a post-market, monocentric, interventional, single-arm, confirmative clinical investigation to evaluate the performance and the safety of PN+HA (NEWEST) for the improvement of skin hydration.
- Trial name
- NCT06821867
- Testing
- PN + HA (Newest)
- Where
- Italy
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Mastelli S.r.l
Solid Tumor
A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors
This Phase I/II clinical study, titled "A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors", aims to evaluate the safety and diagnostic performance of F18 FBPA PET/CT imaging in…
- Trial name
- NCT07691775
- Testing
- F18 FBPA Injection
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Heron Neutron Medical Corp.
Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid…
- Conditions
- Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease
- Trial name
- SCOUT-II (NCT03225612)
- Testing
- Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
- Where
- 11 sites in Germany, Italy and 2 more
- Volunteers
- 60 people
- Sponsor
- Mitralign, Inc.
Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate (MF)
The primary objective of the study is to evaluate the safety and effectiveness of OCEAN as an adjunct aid in wound healing after nasal/sinus surgery and to demonstrate that OCEAN is non-inferior compared to a steroid-eluting…
- Trial name
- ENHANCE II (NCT07286201)
- Testing
- OCEAN, Steroid-eluting sinus stent
- Where
- 9 sites in United States
- Volunteers
- 110 people
- Sponsor
- Polyganics BV
Disk Herniated Lumbar
Safety and Performance of a Hernia Blocking System
Prospective, multi-center, single-arm clinical study to assess the performance of an Hernia Blocking System in preventing clinically symptomatic recurrent lumbar disc herniation.
- Trial name
- NCT04188236
- Testing
- Hernia Blocking System
- Where
- 6 sites in Spain
- Volunteers
- 30 people
- Sponsor
- NEOS Surgery
Non-Valvular Atrial Fibrillation
Evaluation of Safety and Performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk
The purpose of the study is to assess the safety and performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in LAA (Left Atrial Appendage) closure for patients with non-valvular atrial…
- Trial name
- Omega (NCT04829929)
- Testing
- Omega™LAA Occluder implantation
- Where
- 13 sites in Denmark, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Eclipse Medical Ltd.
Sleep Disorder
Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions
Safety and performance study of the MemoWave electroencephalographic and sound recording device to increase slow brain waves during sleep to improve memory consolidation in subjects with mild cognitive impairment
- Trial name
- MEMOWAVE (NCT04875442)
- Testing
- Memowave emitting sounds, Memowave not emitting sounds
- Where
- France
- Sponsor
- BioSerenity
Hearing Loss, Conductive, Hearing Loss, Mixed
Pediatric Expansion Study of the Sentio System
This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Single Sided Deafness
- Trial name
- BC119 (NCT06976086)
- Testing
- Active transcutaneous bone conduction system
- Where
- 8 sites in Netherlands, Spain and 1 more
- Volunteers
- 50 people
- Sponsor
- Oticon Medical
Mechanically Ventilated Patients
Pilot Clinical Investigation to Evaluate a Prototype of Sensor Measuring Ventilator-derived Parameters
Recently, the threat of viral pandemics (Covid-19, severe acute respiratory syndrome, avian flu H5N1, and H1N1), which might result in thousands of patients requiring mechanical ventilation, has accelerated the need for…
- Trial name
- NCT06054503
- Testing
- prototype of sensor
- Where
- France
- Volunteers
- 59 people
- Sponsor
- Archeon
Degenerative Disc Disease, Cervical Spinal Instability
Cervical Interbody Implant Study
The primary objective of this study is to evaluate the safety and performance of cervical spine surgery using interbody implants as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).
- Trial name
- NCT04689854
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- NuVasive
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