Clinical trials: Safety and Performance
Aneurysm, Intracranial
An EFS Assessing the Electrolytic eCLIPs System for Treatment of Intracranial Aneurysms
The purpose of this study is to investigate the feasibility and initial clinical safety of eCLIPs device use for the treatment of wide-necked bifurcation aneurysms.
- Trial name
- NCT04886505
- Testing
- Electrolytic eCLIPs Bifurcation System
- Sponsor
- Evasc Medical Systems Corp.
Cardiac Arrhythmia
An Evaluation of the Safety and Performance of the CathVision Cube® System
The primary objective is to evaluate the safety and technical performance of the CathVision Cube® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available…
- Trial name
- NCT05114382
- Testing
- EP Procedure
- Where
- 2 sites in Czechia, Denmark
- Volunteers
- 24 people
- Sponsor
- CathVision ApS
Tricuspid Regurgitation
Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study
A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft System. Twenty (20) patients in 8 investigational sites will be enrolled.
- Trial name
- NCT04289870
- Testing
- Trillium™
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 20 people
- Sponsor
- Innoventric LTD
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Romania Satellite Registry
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Trial name
- NCT01593059
- Where
- 4 sites in Romania
- Volunteers
- 13 people
- Sponsor
- Biotronik Vertriebs-GmbH
Healthy, Pregnant Women
Comparative Performance of INVU™ Versus Intrauterine Pressure Catheter (IUPC) in Uterine Contractions Monitoring of Pregnant Women.
The primary objective of this research is to assess the agreement between INVU™ and IUPC (the gold standard) during prenatal monitoring of uterine contractions and to assess the safety of INVU™.
- Trial name
- NCT03889405
- Testing
- INVU™, IUPC, TOCO
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Nuvo-Group, Ltd.
Acute Ischemic Stroke
FIrst-Pass Reperfusion With the NeVa Stent-Retriever Trial
This study is designed to compare the safety, performance and efficacy of blood clot (thrombus) removal in subjects presenting with acute ischemic stroke with the NeVa versus the Solitaire stent retrievers.
- Trial name
- FIRST (NCT04072367)
- Testing
- NeVa Stent Retrievers, Solitaire Stent Retrievers
- Sponsor
- Vesalio
Aortic Valve Stenosis
VitaFlowTM II Transcatheter Aortic Valve System Study
A prospective, single arm clinical investigation evaluating safety and effectiveness/performance of the Microport CardioFlow VitaFlowTM II - Transcatheter Aortic Valve System for the treatment of symptomatic severe aortic…
- Trial name
- NCT03575039
- Testing
- VitaFlow II Transcatheter Aortic Valve System
- Volunteers
- 178 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Carotid Artery Diseases, Stroke
Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting
The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous US IDE carotid stenting with…
- Trial name
- WISE (NCT01783639)
- Testing
- Carotid Artery Stent
- Where
- 10 sites in Belgium, Germany and 1 more
- Volunteers
- 120 people
- Sponsor
- Gardia Medical
Chronic Spinal Cord Injury
LIFT Home Study of Non-Invasive ARC Therapy for Spinal Cord Injury
The LIFT Home Study is an observational, single-arm study designed to assess the safety of non-invasive electrical spinal stimulation (ARC Therapy) administered by the LIFT System to treat upper extremity functional deficits in…
- Trial name
- NCT05284201
- Testing
- LIFT System
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- ONWARD Medical, Inc.
Hallux Limitus of Left Great Toe, Rheumatoid Arthritis
Mid-term Outcomes of First MTP Arthroplasty With Primus™ FGT Implant.
Foot silicone implants suffer from bad reputation on the market, due to poor results obtained with the first generations of implants.
- Conditions
- Hallux Limitus of Left Great Toe, Rheumatoid Arthritis, Arthritis of 1st Metatarsophalangeal Joint, Osteoarthritis
- Trial name
- NCT02350881
- Testing
- Primus FGTI (Flexible Great toe Implant)
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- Stryker Trauma and Extremities
Age-related Cataract, Vision Loss
Long-term Safety & Performance of REVISYON SDS100 in Mild to Moderate Cataract: Extension Study (EB-CE-02)
A non-interventional, extension study on the long-term maintenance of safety and performance of the REVISYON SDS 100 medical device in subjects with mild-to-moderate cataract.
- Conditions
- Age-related Cataract, Vision Loss, Cataract, Mild Cataract
- Trial name
- EB-CE-02 (NCT07246915)
- Where
- 6 sites in Romania
- Volunteers
- 47 people
- Sponsor
- Edinburgh Biosciences Ltd
Severe to Profound Hearing Loss
Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants.
This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized.
- Trial name
- BELPS (NCT07777562)
- Testing
- Cochlear implantation
- Where
- Switzerland
- Volunteers
- 700 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
Acute Ischemic Stroke
The Vesalio NeVa Stent Retriever Registry Study for Treatment of Large Vessel Occlusion Strokes
A prospective, open label, 90-day study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.
- Trial name
- NCT03926988
- Testing
- NeVa Stent Retriever
- Where
- Spain
- Volunteers
- 400 people
- Sponsor
- Vesalio
Glaucoma
Minimally Invasive Micro Sclerostomy: Performance and Safety Evaluation Study
Eligible Glaucoma patients will undergo pre-surgery examination including: medicines list, blood tests and ECG. On surgery day: intraocular pressure (IOP) will be measured.
- Trial name
- NCT04503590
- Testing
- Minimally Invasive Micro Sclerostomy (MIMS)
- Where
- Armenia
- Volunteers
- 120 people
- Sponsor
- Sanoculis Ltd
Wrinkles, Anti Aging
PER-SAF_PDOS (Performance and Safety of Polydioxanone Suture)
This clinical investigation aims to confirm the safety and efficacy of the ID in facial soft tissue reconstruction, specifically for non-incision surgery to tighten and lift the facial skin for a rejuvenated facial appearance.
- Conditions
- Wrinkles, Anti Aging, Face-lift
- Trial name
- PER-SAF_PDOS (NCT07068061)
- Testing
- PDO suture
- Volunteers
- 50 people
- Sponsor
- 21 Century Medical Co., Ltd.
Diagnostic Imaging, Neoplasms
Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY94-9392 in patients with cancer or inflammation.
- Trial name
- NCT01103310
- Testing
- BAY94-9392
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Lantheus Biosciences Ltd.
Peripheral Nerve Injuries
Continuous Observational Monitoring Program for Allay™ Hydrogel Cap Safety and Success Study
is is a multi-center, open-label, observational registry study (both prospective and retrospective) designed to evaluate the safety and performance of the allay™ Hydrogel Cap.
- Trial name
- COMPASS (NCT07246980)
- Testing
- Nerve Cap
- Where
- 5 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Tulavi Therapeutics,Inc.
Alzheimer's Disease
Effect on Cognitive Performance and Safety/Tolerability of SSR180711C in Mild Alzheimer's Disease
The primary objective of the study is to assess the effect of 3 doses of SSR180711C on cognitive performance in patients with mild Alzheimer's Disease (AD).
- Trial name
- NCT00602680
- Testing
- SSR180711C, donepezil
- Where
- France
- Volunteers
- 1 people
- Sponsor
- Sanofi
Arthroplasty Complications, Osteo Arthritis Shoulders
Comprehensive SRS Regenerex Tissue Attachment
The objective of this retrospective and prospective consecutive series data collection is to confirm safety, performance, and clinical benefits of the Comprehensive SRS Regenerex Tissue Attachment Augments when used for limb…
- Trial name
- NCT06615739
- Testing
- Regenerex Tissue Attachment Augments
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Zimmer Biomet
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