Clinical trials: Safety and Performance
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
Atrial Fibrillation, Left Atrial Appendage
Zenith LAA Occlusion System
Demonstrate the safety and performance of the Zenith LAA Occlusion System and procedure to occlude the Left Atrial Appendage (LAA) from the left atrium (LA) using a minimally invasive technique.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage, Stroke
- Trial name
- NCT05951101
- Testing
- Zenith LAA Occlusion System
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 10 people
- Sponsor
- AuriGen Medical Ltd
Stroke, Parkinson Disease
Videofluoroscopic Swallowing Study (VFSS)
The study procedure of simultaneous VFSS and DDS measurement will be completed in one day and the subject will be followed within 2 business days after the study procedure to monitor for adverse events.
- Conditions
- Stroke, Parkinson Disease, Multiple Sclerosis, Oropharyngeal Dysphagia
- Trial name
- PORSCHE (NCT03387267)
- Testing
- Dysphagia Detection System
- Where
- 13 sites in United States, Finland
- Volunteers
- 452 people
- Sponsor
- Société des Produits Nestlé (SPN)
Vascular Closure, Femoral Arteriotomy Closure
The Ladera Suture-Mediated Large Bore Closure Study
This study evaluates the safety and performance of the Ladera Medical suture-mediated large bore closure (LBC) system in gaining post procedure hemostasis in subjects undergoing interventional catheterization procedures using a…
- Trial name
- FASTEN (NCT06851481)
- Testing
- Ladera LBC System
- Where
- 6 sites in Australia, Belgium and 1 more
- Volunteers
- 55 people
- Sponsor
- Ladera Medical
Primary Open Angle Glaucoma
Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) Glaucoma Drainage Implant
To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg
- Trial name
- NCT01563237
- Testing
- MIDI Arrow
- Where
- France
- Volunteers
- 69 people
- Sponsor
- InnFocus Inc.
Wound of Skin
Safety and Performance of SWIS in Superficial Wounds
This is an open, evaluator blinded, intra-comparative, randomized, non-inferiority investigation prior to CE mark to confirm safety and performance of the SWIS device when used as intended, i.e.
- Trial name
- NCT04771819
- Testing
- SWIS
- Where
- Denmark
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- SoftOx Solutions AS
Glaucoma Eye, Tissue Breakdown
Pivotal Trial for a Synthetic Tissue Substitute for Concealment of Artificial Ocular Implants
This clinical trial will assess the clinical safety and performance of the CorNeat EverPatch device used as a tissue substitute for concealment of artificial ocular implants.
- Trial name
- EverPatch (NCT05469867)
- Testing
- CorNeat EverPatch
- Where
- Georgia
- Volunteers
- 12 people
- Sponsor
- CorNeat Vision Ltd.
Atrial Fibrillation
Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
- Trial name
- PULSE-EU (NCT05164107)
- Testing
- Globe Mapping and Pulsed Field Ablation System (Globe PF System)
- Where
- Czechia
- Volunteers
- 175 people
- Sponsor
- Kardium Inc.
Ethmoid Sinusitis
Sinopsys® Lacrimal Stent Indicated for Sinus Irrigation
The primary objective is to evaluate clinical data related to the safety and performance of the Sinopsys® Lacrimal Stent.
- Trial name
- NCT03304951
- Testing
- Sinopsys® Lacrimal Stent
- Where
- Czechia
- Volunteers
- 8 people
- Sponsor
- Sinopsys Surgical
Heart Failure, Ventricular Dysfunction
Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy
The WiCS-LV system is an alternative means to providing left ventricular stimulation for Cardiac Resynchronization Therapy (CRT).
- Conditions
- Heart Failure, Ventricular Dysfunction, Cardiomyopathy
- Trial name
- WiSE-CRT (NCT01294527)
- Testing
- Wireless cardiac stimulator implant to pace the left ventricle for CRT
- Where
- 10 sites in France, Germany and 2 more
- Volunteers
- 17 people
- Sponsor
- EBR Systems, Inc.
Knee Osteoarthritis (Knee OA)
Knee OsteoArthritis Long-term Assessment
The goal of this clinical study is to learn if Hydrogel OA 2% injection is safe and whether it works to improve symptoms of diagnosed knee osteoarthritis in adults when compared to Hyaluronic Acid (Durolane), a treatment that is…
- Trial name
- KOALA (NCT06839222)
- Testing
- Hydrogel OA 2%, Hyaluronic Acid (Durolane)
- Where
- 5 sites in Belgium
- Sponsor
- Allegro NV/SA
Retention, Urinary
Investigation of New Intermittent Catheters in Healthy Volunteers
Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.
- Trial name
- NCT04445051
- Testing
- SpeediCath® Standard male or female, New intermittent Variant 1 catheter for male or female, New intermittent Variant 2 catheter for male or female
- Where
- Denmark
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Marginal Zone Lymphoma
[68Ga]Ga-PentixaFor-PET Imaging for Staging of Marginal Zone Lymphoma
This will be a pivotal prospective prospective, international, multi-center, comparative, randomized, cross-over, open-label lymphoma diagnostic trial to assess the diagnostic performance and safety of the positron emission…
- Trial name
- LYMFOR (NCT06125028)
- Testing
- [68Ga]Ga-PentixaFor, [18F]Fluorodeoxyglucose
- Where
- 12 sites in Austria, France and 3 more
- Volunteers
- 8 people
- Sponsor
- Pentixapharm AG
Aortic Valve Stenosis
Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV).
- Trial name
- TAB-R (NCT02099942)
- Testing
- V8 Balloon Aortic Valvuloplasty (BAV) Catheter
- Where
- 7 sites in United States
- Volunteers
- 103 people
- Sponsor
- InterValve, Inc.
Atrial Fibrillation, Atrial Flutter
Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System for Treatment of Atrial and Ventricular Arrhythmias
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and RF Ablation System to treat Atrial Arrhythmias
- Conditions
- Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia
- Trial name
- NCT04211441
- Testing
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Where
- 2 sites in Czechia
- Volunteers
- 74 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
Breast Implant; Complications, Quality of Life
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface
The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years.
- Conditions
- Breast Implant; Complications, Quality of Life, Satisfaction, Safety and Performance
- Trial name
- STEPS S (NCT05345821)
- Where
- Brazil
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Silimed Industria de Implantes Ltda
Heart Failure
NoYA RAISE Trial II (Radiofrequency Ablation-Based Interatrial Shunt for Heart Failure)
A Prospective, Multiple Center, and Objective Performance Criteria Study to Evaluate the NoYA™ Radiofrequency Interatrial Shunt System manufactured by NoYA Medtech (Hangzhou) Co., Ltd.
- Trial name
- NCT05375110
- Testing
- NoYA™ Radiofrequency Interatrial Shunt System
- Where
- 31 sites in China
- Volunteers
- 120 people
- Sponsor
- Hangzhou NOYA MedTech Co. Ltm.
Cardiac Surgery, Thoracic Surgery
Heart Lung Machine Registry
The HeaLMe post-market clinical follow-up registry is undertaken to evaluate the safety and performance of the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric in patients undergoing…
- Conditions
- Cardiac Surgery, Thoracic Surgery, Vascular Surgery, Cardiopulmonary Bypass
- Trial name
- HeaLMe (NCT06159517)
- Where
- 3 sites in Italy, Spain
- Volunteers
- 184 people
- Sponsor
- Maquet Cardiopulmonary GmbH
Coronary Artery Disease
Non-inferiority Trial to Assess the Safety and Performance of the Evolution Coronary Stent
The purpose of the EVOLVE Trial is to assess the safety and performance of the everolimus-eluting Evolution stent for the treatment of a de novo atherosclerotic lesion of up to 28 mm in length in a native coronary artery 2.25 mm…
- Trial name
- Evolve (NCT01135225)
- Testing
- PROMUS(TM) Element (TM) Stent System, Evolution Stent System
- Where
- 29 sites in Australia, Belgium and 7 more
- Volunteers
- 291 people
- Sponsor
- Boston Scientific Corporation
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