Clinical trials: Safety and Performance
Peripherally Inserted Central Catheter
Comparing Arrow PICC Catheters w/ Arrowga+rd Blue Advanced Protection Performance and Safety to Unprotected PICC's
This study seeks to compare the standard unprotected PICC with the AGBA PICC for placement success, incidence of venous thrombosis through duplex ultrasound, observing for signs and symptoms of thrombotic occlusion and recording…
- Trial name
- NCT05278507
- Testing
- Arrowga+rd Blue Advance Protection PICC Placement
- Where
- 5 sites in China
- Volunteers
- 444 people
- Sponsor
- Teleflex
Knee Osteoarthritis
Comparative Evaluation of A-CP HA Kit, Hyaluronic Acid and Placebo for the Treatment of Knee Osteoarthritis
Hyaluronic acid (HA) is a major component of synovial fluid, to which it confers viscosity and elasticity. It has been shown that the rheological properties of the synovial fluid decrease in patients with osteoarthritis.
- Trial name
- NCT03201614
- Testing
- A-CP HA Kit, ArthroVisc 40
- Where
- United States
- Volunteers
- 290 people
- Sponsor
- Regen Lab SA
Fractures, Bone, Fractures, Closed
Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System
This is an open-label, prospective, observational, post-market, uncontrolled, multi-center study intended to evaluate the safety and clinical performance of the FITBONE Transport and Lengthening Nail when used according to the…
- Conditions
- Fractures, Bone, Fractures, Closed, Fractures, Open, Fracture of Femur
- Trial name
- NCT06400732
- Testing
- Fitbone Transport and Lengthening System
- Where
- 9 sites in United States
- Volunteers
- 1 people
- Sponsor
- Orthofix Inc.
Dry Eye, Dry Eye Disease
PMCF Study to Evaluate Performance and Safety of "Ocular Drops Based Upon Carmellose" Used to Relieve Dry Eye Symptoms
Dry eye disease (DED), also called keratoconjunctivitis sicca, is a multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film and accompanied by symptoms such as ocular discomfort and…
- Conditions
- Dry Eye, Dry Eye Disease, Kerato Conjunctivitis Sicca
- Trial name
- NCT05825352
- Testing
- Carmellose eye drops
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- C.O.C. Farmaceutici S.r.l.
Wide Neck Intracranial Aneurysms
Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms
The purpose of this study is to assess the safety and performance of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms.
- Trial name
- NCT01753388
- Testing
- Liberty Stent
- Where
- 4 sites in Germany
- Sponsor
- Penumbra Inc.
Carotid Artery Stenosis
Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)
Clinical Trial Summary Trial Title:** CREATE Trial: Safety and Efficacy of IVL for Carotid Calcified Lesions Sponsor:** Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
- Trial name
- CREATE (NCT06936176)
- Testing
- Neurovascular Intravascular Shockwave Catheter
- Where
- China
- Volunteers
- 204 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Obstructive Sleep Apnea
BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse
The objective of this study is to explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate over a period of 4.5…
- Trial name
- BETTER SLEEP (NCT03763682)
- Testing
- Genio(TM) bilateral hypoglossal nerve stimulation system
- Where
- 4 sites in Australia
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Nyxoah S.A.
Atherosclerosis, Arteriosclerosis
BIOLUX P-I First in Man Study
A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs.
- Conditions
- Atherosclerosis, Arteriosclerosis, Vascular Disease, Peripheral Artery Disease
- Trial name
- NCT01221610
- Testing
- Passeo-18 Lux DRB, Standard PTA (POBA)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 60 people
- Sponsor
- Biotronik AG
Aortic Valve Stenosis
The Leaflex™ Early Feasibility Study
A prospective, multicenter, single-arm, early feasibility study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis.
- Trial name
- NCT04636073
- Testing
- Leaflex™ Performer
- Sponsor
- Pi-cardia
End Stage Renal Disease
Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts
The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE grafts for effectiveness in maintaining primary or assisted primary patency.
- Trial name
- NCT00131872
- Testing
- Expedial Vascular Access Graft
- Where
- 8 sites in United States
- Volunteers
- 172 people
- Sponsor
- LeMaitre Vascular
Musculoskeletal Disorder
Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Musculoskeletal Disorders
Evaluate the evolution of locomotor abilities in patients treated with functional electrostimulation and biofeedback (PHENIX LIBERTY VIVALTIS device) for musculoskeletal disorders of the knee and spine.
- Trial name
- NCT05926739
- Testing
- Electrical stimulation and biofeedback with Phenix Liberty medical device
- Where
- France
- Volunteers
- 27 people
- Sponsor
- Vivaltis
Benign Gallbladder Disease
Levita Magnetic Grasper Device Safety and Performance Study
The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and Performance in Laparoscopy.
- Trial name
- NCT02049983
- Testing
- Use of Levita Magnetics Grasper
- Where
- 3 sites in Chile
- Volunteers
- 50 people
- Sponsor
- Levita Magnetics
Tibia Fracture
OIF/β-TCP in Patients With Open Tibial Fractures in Need of Bone Grafting
A prospective, randomized, evaluator-blinded, controlled study for subjects with open tibial fractures classified as Gustilo type II, IIIA or IIIB (see Appendix 1) who will receive bone graft implantation for the potential of…
- Trial name
- NCT04960722
- Testing
- OIF/β-TCP
- Where
- Taiwan
- Volunteers
- 35 people
- Sponsor
- BioGend Therapeutics Co.Ltd
Tachyarrhythmias
SecuraTM ICD Clinical Evaluation Study
The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)
- Trial name
- NCT00526227
- Testing
- Secura ICD
- Where
- 13 sites in Austria, Finland and 5 more
- Volunteers
- 81 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Burns
Continued Access to the Recell® Device for Treatment of Acute Burn Injuries
The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review.
- Trial name
- NCT03333941
- Testing
- ReCell® Autologous Cell Harvesting Device
- Where
- 6 sites in United States
- Volunteers
- 76 people
- Sponsor
- Avita Medical
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.
Laxity; Skin, Volume Deficiency in the Mid-Face
Prospective Clinical Evaluation of the Safety and Performance of the Aesthetic Medical Device MEC REGENERATE® (Injectable Recombinant Collagen-based Product)
Prospective, spontaneous, open-label pre-market clinical trial with a single injection session; monitoring visits at baseline and 60 days post-treatment.
- Conditions
- Laxity; Skin, Volume Deficiency in the Mid-Face, Wrinkles
- Trial name
- NCT07413445
- Testing
- Treatment with experimental device
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- 303 Pharma s.r.l.
Clostridium Difficile Infection
Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI)
The purpose of this study is to determine the safe use and evaluate the efficacy/performance of DAV132 in hospitalized patients at high risk for Clostridium difficile infection (CDI) and who receive fluoroquinolones (FQs) for the…
- Trial name
- SHIELD (NCT03710694)
- Testing
- DAV132
- Where
- 29 sites in Bulgaria, Germany and 2 more
- Volunteers
- 260 people
- Sponsor
- Da Volterra
Respiratory Insufficiency, Respiratory Failure
Safety and Performance of NivolisMonitor and NivolisAnton for Monitoring Patients on Ventilatory Assistance at Home
NivolisMonitor and NivolisAnton are new devices developed by Vivardis. NivolisMonitor is a generic and autonomous device for remote monitoring of ventilatory parameters generated by ventilatory assistance systems.
- Conditions
- Respiratory Insufficiency, Respiratory Failure, Home Monitoring
- Trial name
- NCT05698602
- Testing
- NivolisMonitor, NivolisAnton
- Where
- France
- Volunteers
- 10 people
- Sponsor
- VIVARDIS
Senile Cataract
Safety and Performance of Hydrophobic and Hydrophilic Intraocular Lenses After Bilateral Cataract Surgery
Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery
- Trial name
- NCT06192901
- Where
- El Salvador
- Volunteers
- 8 people
- Sponsor
- Carl Zeiss Meditec AG
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