Clinical trials: Safety and Performance
Refractory Paroxysmal Atrial Fibrillation
A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)
The purpose of this study is to evaluate the long term off-Antiarrhythmic Drug (AAD) effectiveness of Biosense Webster, Inc. Irreversible Electroporation (BWI IRE) system in treatment of participants with symptomatic drug…
- Trial name
- AFIRE (NCT05552963)
- Testing
- Multi-Channel Irreversible Electroporation (IRE) Generator, Multi-Channel Circular IRE Catheter
- Where
- 6 sites in China
- Volunteers
- 142 people
- Sponsor
- Biosense Webster, Inc.
Parkinson Disease, Cognitive Impairment
Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease
Prospective trial of low frequency deep brain stimulation of the ventral subthalamic nucleus to improve cognitive performance in patients with advanced Parkinson's disease.
- Trial name
- NCT03204526
- Testing
- deep brain stimulation
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of California, Davis
Coronary Artery Disease
BIOTRONIK Orsiro Pre-Marketing Registration
The clinical investigation is a non-inferiority, multicenter, blinding evaluation, randomized, parallel controlled clinical study enrolling up to 440 subjects.
- Trial name
- BIOFLOW-VI (NCT02870985)
- Testing
- Coronary Stent
- Where
- China
- Volunteers
- 440 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
Non-Squamous Non-Small Cell Lung Cancer
An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)
This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of…
- Trial name
- ELEMENT (NCT01836133)
- Testing
- Erlotinib 150 mg
- Where
- 5 sites in Serbia
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
Cataract
Clinical Study to Evaluate the Safety and Performance of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction
The objective of the study is to evaluate the safety and performance of the enVista trifocal intraocular lens when implanted in the capsular bag.
- Trial name
- NCT04224155
- Testing
- enVista MX60EFH trifocal intraocular lenses (IOLs), enVista MX60E monofocal intraocular lenses (IOLs)
- Where
- 9 sites in Canada
- Volunteers
- 165 people
- Sponsor
- Bausch & Lomb Incorporated
Bacteremia, Bacterial Infection
Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis
The purpose of this study is to determine whether the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is safe in the treatment of dialysis patients with bacteremia.
- Trial name
- NCT02914132
- Testing
- Seraph 100 Filter
- Where
- 4 sites in Germany
- Volunteers
- 15 people
- Sponsor
- ExThera Medical Corporation
HSV-2 Infection, Genital Herpes
The VIBLOK SAfety and perFormancE Trial
Genital herpes has a high prevalence in industrialized as well as developing countries. Genital herpes causes genital ulcers, increases risk for acquiring HIV infection, and may be transmitted mother to child during birth with…
- Trial name
- SAFE (NCT03080961)
- Testing
- VIBLOK barrier cream
- Where
- 3 sites in Netherlands
- Volunteers
- 82 people
- Sponsor
- CLJI Worldwide
Dry Eye
Performance and Safety of T2769 in DED
To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment. To evaluate the performance and safety of T2769 versus Vismed® Multi.
- Trial name
- NCT05965778
- Testing
- T2769, Vismed® Multi
- Where
- France
- Volunteers
- 251 people
- Sponsor
- Laboratoires Thea
Sinusitis
Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium
The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.
- Trial name
- NCT01623050
- Testing
- SinuSys Dilation System
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 36 people
- Sponsor
- SinuSys Corporation
Sarcopenia, Gait Disorders in Old Age
A Double-blind, Placebo-controlled, Randomized INTerventional Clinical Trial (SARA-INT)
The main objective of the study is to evaluate the effect of two daily doses of BIO101 versus placebo on mobility function as measured by gait speed using the 400MW test.
- Conditions
- Sarcopenia, Gait Disorders in Old Age, Muscle Weakness
- Trial name
- SARA-INT (NCT03452488)
- Testing
- BIO101
- Where
- 22 sites in United States, Belgium
- Volunteers
- 233 people
- Sponsor
- Biophytis
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device in Poland
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT02432196
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
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
Malignant Wounds
A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds
This is a prospective, open, non-controlled clinical investigation to evaluate the performance and safety of using Mepilex Transfer Ag on a malignant wound.
- Trial name
- NCT02431741
- Testing
- Mepilex Transfer Ag
- Where
- 2 sites in Czechia
- Volunteers
- 14 people
- Sponsor
- Molnlycke Health Care AB
Contraception: Optional Applicator for Insertion of Vaginal Ring
Performance and Safety of Vaginal Ring Applicator in Healthy Females (MK-8342A-063)
The purpose of the study is to assess the performance and safe use of the vaginal ring applicator as an optional aid for insertion of a placebo vaginal ring into the vagina in healthy women
- Trial name
- NCT02275546
- Testing
- Single-use, non-sterile applicator
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Mitral Regurgitation
Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.
To evaluate the long-term safety and performance of the HARPOON™ MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.
- Trial name
- ASCEND (NCT04382612)
- Testing
- HARPOON Beating Heart Mitral Valve Repair System (MVRS)
- Where
- 10 sites in Austria, Germany and 2 more
- Volunteers
- 42 people
- Sponsor
- Edwards Lifesciences
End Stage Renal Disease
Pilot Study to Evaluate Safety, Tolerability, and Performance of the FAST PV Technology™ in Chronic Dialysis Patients
The FAST Plasma Volume (PV) Technology will aid in determining the plasma and interstitial volumes of end stage renal disease patients before and after dialysis therapy, providing a more precise understanding of pre and post…
- Trial name
- NCT04733664
- Testing
- VFI using the FAST PV Technology
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- FAST BioMedical
Cellulite
Profound Dermal and SubQ Cartridges for the Treatment of Cellulite
Clinical Study to Evaluate the Performance of the Profound System for the Treatment of Cellulite.
- Trial name
- NCT03078647
- Testing
- Profound
- Where
- 2 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Syneron Medical