Clinical trials: Safety and Performance
Cardiac Arrhythmia
An Evaluation of the Safety and Performance of the CathVision ECGenius® System.
The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available…
- Trial name
- NCT05301803
- Testing
- Electrophysiology procedure
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- CathVision ApS
Ventricular Tachycardia
Unpinning Termination Therapy for VT (US)
This observation study evaluates the safety and performance of UPT therapy in subjects during either an indicated ventricular tachycardia ablation procedure or an ICD implant procedure.
- Trial name
- NCT03093051
- Testing
- Unpinning Termination therapy
- Where
- 7 sites in United States
- Volunteers
- 6 people
- Sponsor
- Cardialen, Inc.
Meniscus Tears
Evaluation of the Performance and Safety of a Single-dose Hyaluronic Acid (Promovia Hydro Balance) in the Treatment of Non-traumatic Degenerative Meniscus Tears
Evaluation of the performance and safety of a single-dose hyaluronic acid (Promovia hydro balance) in the treatment of non-traumatic degenerative meniscus tears
- Trial name
- NCT07539194
- Testing
- Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- Innate srl
Chronic Obstructive Airway Disease
Clinical Study to Investigate Safety and Performance of NeuRx DPS in Patients Undergoing Bilateral Lung Transplantation
This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from…
- Trial name
- NCT02411383
- Testing
- NeuRx Diaphragm Pacing System
- Where
- Belgium
- Volunteers
- 4 people
- Sponsor
- Synapse Biomedical
Musculoskeletal Disorders, Skeletal Disorder
Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World
DJO UK Ltd (ENOVIS) is conducting this study to confirm the performance and safety of the Chattanooga Intelect® devices in real world use.
- Conditions
- Musculoskeletal Disorders, Skeletal Disorder, Muscle Disorder
- Trial name
- INTELECT (NCT06809283)
- Where
- 4 sites in France, Italy and 1 more
- Volunteers
- 144 people
- Sponsor
- DJO UK Ltd
Obesity
Safety and Performance of the OTTAVA Robotic System
This study assesses safety and performance of the OTTAVA Robotic System, through 30 days postoperative, in subjects undergoing robotic-assisted Roux-en-Y Gastric Bypass (RYGB) procedure.
- Trial name
- FORTE (NCT06709261)
- Testing
- OTTAVA Robotic System
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- Auris Health, Inc.
Overactive Bladder
Overactive Bladder Posterior Tibial Implantable MIcro STimulator - 1
Interventional, Prospective, Open Label study
- Trial name
- OPTIMIST-1 (NCT03019094)
- Testing
- The RENOVA tibial nerve stimulation system
- Sponsor
- BlueWind Medical
Localized T1-T2 Prostate Cancer
SpaceOAR System RWS in China
This study aims to evaluate the safety and performance of SpaceOAR System when it is used to create space between the rectum and prostate in men undergoing radiotherapy for localized T1-T2 prostate cancer in China via collecting…
- Trial name
- NCT05407714
- Testing
- SpaceOAR Treatment
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Total Knee Arthroplasty
Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts
The purpose of this research is to collect data on patients that had the Legion CR Oxinium and CoCr Femoral Implant and the Legion/Genesis II XLPE High Flex Tibial Inserts implanted in the past.
- Trial name
- Legion Oxinium (NCT03687593)
- Testing
- Legion™ CR Oxinium and CoCr Femoral Implants combined with Legion™/Genesis™ II XLPE High Flex Tibial Inserts
- Where
- 4 sites in United States
- Volunteers
- 126 people
- Sponsor
- Smith & Nephew, Inc.
Cataract, Presbyopia
Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens
This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.
- Trial name
- PSM15 (NCT02838004)
- Testing
- IOL MINI WELL READY
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- SIFI SpA
Hernia, Inguinal
Safety and Performance of the OTTAVA System in Participants Undergoing Inguinal Hernia Repair
The purpose of this study is to assess safety and performance of the OTTAVA System, through 30 days postoperative, in participants undergoing robotic-assisted inguinal hernia repair (IHR).
- Trial name
- TEMPO (NCT07298317)
- Testing
- OTTAVA Robotic System
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Auris Health, Inc.
Acne Scars
Clinical Evaluation of Fractional Radiofrequency for the Treatment Acne Scarring
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of acne scarring.
- Trial name
- NCT03821324
- Testing
- Venus Viva
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Abdominal Vascular Surgery, Peripheral Vascular Surgery
A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C
Purpose of the study is to describe safety and performance of POLYMAILLE® C from a minimum of 200 subjects will be evaluated. A minimum of 100 subjects will be evaluated for each main location of surgery (abdominal and…
- Conditions
- Abdominal Vascular Surgery, Peripheral Vascular Surgery, Vascular Prothesis, Aneurysm Abdominal
- Trial name
- NCT05517876
- Testing
- Vascular abdominal or peripheral surgery
- Where
- France
- Volunteers
- 212 people
- Sponsor
- Perouse Medical
Hypertension, Resistant to Conventional Therapy
Baroloop Multicenter Trial (Baroloop MCT)
The goal of this clinical trial is to learn weather the baroloop system is safe and works to treat hypertension in adults that do not respond sufficiently to medication.
- Trial name
- NCT06518915
- Testing
- baroloop system
- Where
- 4 sites in Germany, Netherlands
- Volunteers
- 3 people
- Sponsor
- neuroloop GmbH
Aesthetic Correction of the Lips
Clinical Investigation on Lips Treated With HA-filler
A post-market-clinical follow-up investigation to confirm the clinical safety and performance profile of Decoria® Essence for the correction and improvement of lips profile.
- Trial name
- DAG-ESS (NCT07188818)
- Testing
- Decoria Essence
- Where
- 6 sites in Sweden
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Bohus Biotech AB
Dry Eye
Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.
This is a confirmatory clinical investigation. The objective is to collect new additional clinical data demonstrating the safety and performance of the device in the contact-lens wearing population with dry eyes.
- Trial name
- NCT05931861
- Testing
- T2769
- Where
- 6 sites in Bulgaria
- Volunteers
- 34 people
- Sponsor
- Laboratoires Thea
Dermal Filler, Volume Deficiency of the Midface
An Interventional Study to Evaluate the Safety and Performance of Crosslinked Hyaluronic Acid Hydrogel
The aim of this interventional, pre-market, double- blinded, controlled, two stages study is to evaluate the performance and safety of Crosslinked Hyaluronic Acid (CLHA) Hydrogel (with and without Lidocaine) for the Treatment of…
- Trial name
- NCT05853224
- Testing
- Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without Lidocaine
- Where
- Italy
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Biopolimeri Srl
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
Binocular Vision Disorder, Binocular Eye Movement Disorder
Performance and Safety Evaluation of the S360 Medical Device Software.
The aim of this interventional, cross-sectional study is to evaluate the performance and the safety of the medical device software S360.
- Conditions
- Binocular Vision Disorder, Binocular Eye Movement Disorder, Ocular Motion; Disorder
- Trial name
- ArgoS360 (NCT05522595)
- Testing
- S360
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Sierra Neurovision
Skin Wounds, Abrasion
A Study to Evaluate the Safety and Clinical Performance of a Dexpanthenol Medicated Hydrogel Patch in the Treatment of Standardized Superficial Abrasions
Clinical evaluation of a Dexpanthenol-medicated wound plaster on standardized superficial skin abrasions
- Trial name
- Dexpanthenol (NCT07642973)
- Testing
- hydrogel plaster with dexpanthenol, Standard plaster
- Where
- Italy
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Wooshin Labottach Co., Ltd.
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