Clinical trials: Clinical Performance
Dry Eye, Contact Lens Acute Red Eye
Performance and Tolerability of the Medical Device LACRIACT
The goal of this study is testing LACRIACT® eye drops, a medical device, to see how well it works and if people can use it safely.
- Conditions
- Dry Eye, Contact Lens Acute Red Eye, Photophobia, Discomfort
- Trial name
- NCT06159569
- Testing
- LACRIACT
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Laboratórios Baldacci S.A
Vascular Access Device
A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices
The objective of Teleflex's Vascular Access Device Registry (VADER) is to provide high-quality data on the performance, safety, and clinical benefits of Teleflex's vascular access devices when used in a real-world setting
- Trial name
- VADER (NCT06604039)
- Testing
- Central venous catheter
- Where
- 3 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Teleflex
Severe Knee Pain, Severe Knee Disability
Persona Revision Knee System EMEA PMCF Study
The purpose of this post-market clinical follow-up study is to confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and Instrumentation in revision Total Knee Arthroplasty.
- Conditions
- Severe Knee Pain, Severe Knee Disability, Revision Arthroplasty
- Trial name
- NCT07843966
- Where
- 2 sites in Denmark, Spain
- Volunteers
- 238 people
- Sponsor
- Zimmer, GmbH
Abdominal Aortic Aneurysm (AAA)
Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms
The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).
- Trial name
- NCT02009644
- Testing
- Subjects who receive the Treovance stent-graft
- Where
- 29 sites in United States
- Volunteers
- 158 people
- Sponsor
- Bolton Medical
Chronic Low Back Pain (CLBP)
Clinical Investigation to Assess the Clinical Effect of the LumbaCure® Intervention on Patients Suffering From Chronic Low Back Pain
Low Back Pain (LBP) is one of the common causes of morbidity worldwide, with a one-month prevalence of 23.3 %. Number of people with LBP reached 577 million people in 2020.
- Trial name
- LumbaCure2302 (NCT06662032)
- Testing
- LumbaCure®, Rehab program
- Where
- 2 sites in Belgium
- Volunteers
- 50 people
- Sponsor
- Odix
Corneal Disease, Corneal Opacity
Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness
A Single Arm, Pivotal, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness
- Conditions
- Corneal Disease, Corneal Opacity, Corneal Injuries
- Trial name
- NCT05694247
- Testing
- CorNeat KPro
- Where
- 6 sites in Canada, France and 2 more
- Volunteers
- 15 people
- Sponsor
- CorNeat Vision Ltd.
Hepatitis C
Clinical Performance Evaluation of DxN HCV Assay
The DxN Hepatitis C Virus (HCV) Assay is an in vitro diagnostic assay intended as an aid in the management of of HCV-infected individuals undergoing antiviral therapy.
- Trial name
- NCT03125408
- Testing
- HCV Assay
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Beckman Coulter, Inc.
Allergic Conjunctivitis, Dry Eye
PMCF Study to Evaluate Performance and Safety of "Optrex Double Action Soothing and Lubricating Drops"
Allergic conjunctivitis (or ocular allergy) and dry eye disease (DED) are two major ocular surface disorders affecting millions of people.
- Conditions
- Allergic Conjunctivitis, Dry Eye, Dry Eye Disease
- Trial name
- NCT05824000
- Testing
- Eye drops for itchy and water eyes
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- C.O.C. Farmaceutici S.r.l.
Breast Cancer
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
- Trial name
- NCT04480814
- Testing
- PIK3CA kit
- Where
- 4 sites in Greece
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pharmassist Ltd
Urodynamics
e۰Sense® Catheter Clinical Investigation
This pre-market study will be conducted on consenting patients undergoing a medically prescribed, invasive, conventional urodynamics (UDS) test using the investigational device (e۰Sense® urodynamic catheters).
- Trial name
- NCT04438499
- Testing
- eSense 7fr Single Sensor Bladder Catheter
- Where
- 2 sites in France, Germany
- Volunteers
- 61 people
- Sponsor
- Laborie Medical Technologies Inc.
Degenerative Disc Disease
Post Marketing Clinical Follow up Study for MagnetOs Putty in Patients With Degenerative Disc Disease
This study is a post-marketing clinical follow-up study for MagnetOs Putty. MagnetOs Putty is a synthetic bone-like material which is routinely used by surgeons as a treatment for patients with degenerative disc disease who will…
- Trial name
- PROGRESS (NCT04128852)
- Testing
- MagnetOs Putty
- Sponsor
- Kuros Biosurgery AG
Kidney Failure, Chronic
Clinical Study to Assess the Performance of the Dialyzer With Endexo™
Endexo™ is an additive that is blended into the fiber solution during manufacturing of the hemodialyzer hollow fibers. The intended purpose of the additive is to increase blood compatibility in the finished dialyzer, which is…
- Trial name
- NCT03536663
- Testing
- Optiflux and Dialyzer with Endexo
- Where
- 3 sites in United States
- Volunteers
- 23 people
- Sponsor
- Fresenius Medical Care North America
Ankle Injuries and Disorders
Observational Study to Evaluate Safety and Performance of the Total Ankle Prosthesis, EasyMove®
This study is a post-market clinical follow-up conducted in order to collect long-term data on safety and performance of the EasyMove prosthesis, which is intended to be implanted in case of total ankle replacement, when used in…
- Trial name
- NCT04944576
- Testing
- Total Ankle Prosthesis, EasyMove®
- Where
- 6 sites in France, Switzerland
- Volunteers
- 82 people
- Sponsor
- FH ORTHO
Cervical Cytology, PAP
Techcyte SureView Cervical Cytology System Clinical Validation Study
The clinical study is a multi-center, retrospective, blinded, matched-pair, two-arm clinical study in which one test assessment and a control assessment of liquid-based cytology (LBC) pap tests are performed and compared to a…
- Trial name
- NCT06767111
- Testing
- Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm in vitro diagnostic (IVD) device
- Where
- United States
- Volunteers
- 4,596 people, healthy volunteers welcome
- Sponsor
- Techcyte, Inc.
Dry Eye, Dry Eye Disease
PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms
Dry eye disease (DED), also called keratoconjunctivitis sicca, is a common ocular condition characterized by a loss of homeostasis of the tear film and inflammation of the ocular surface.
- Conditions
- Dry Eye, Dry Eye Disease, Kerato Conjunctivitis Sicca
- Trial name
- NCT05825599
- Testing
- Hydroxypropyl methylcellulose eye drops
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- C.O.C. Farmaceutici S.r.l.
Degenerative Disc Disease, Spinal Stenosis
New Robotic Assistance System for Spinal Fusion Surgery
The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis
- Trial name
- AQrate (NCT02558621)
- Testing
- AQrate Robotic Assistance System
- Where
- 2 sites in Switzerland
- Volunteers
- 24 people
- Sponsor
- KB Medical SA
Renal Artery Stenosis, Renal Failure
RADIX 2 RENAL STENT Post-Market Retrospective Study
The Carbostent™ Radix 2 stent is a CE marked balloon expandable bare metal stent for the treatment of renal artery stenosis. The aim of this post-market retrospective study protocol P12204, is to collect clinical data on patients…
- Trial name
- RADIX 2 (NCT05612438)
- Testing
- RADIX 2 Stent
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- CID S.p.A.
Coagulation
Clinical Performance Evaluation of Native Whole Blood Samples of Patients on DOACs With the Perosphere ClotChek™
The Perosphere ClotChek™ system consists of a hand-held, battery-operated blood coagulation instrument and disposable test cuvettes for use at the point-of-care (POC).
- Trial name
- NCT07012291
- Testing
- Whole Blood Clotting Time
- Where
- 4 sites in United States
- Volunteers
- 150 people
- Sponsor
- Perosphere Technologies Inc.
Arthroplasty
Arthroplasty Cements Outcomes - A Post-market Follow-up
A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all…
- Trial name
- NCT06354543
- Testing
- Cemented joint arthroplasty
- Where
- 10 sites in France, Italy
- Volunteers
- 1,050 people
- Sponsor
- Teknimed
Lower Back Pain
Safety and Performance of the Elaspine System in the Treatment of the Lumbar Spine
The safety and performance of the Elaspine™ Implant System in the treatment of lower back pain will be evaluated with a prospective and nonrandomized, multicenter post-marketing clinical study (PMCS).
- Trial name
- NCT01323543
- Testing
- Elaspine™
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 40 people
- Sponsor
- Spinelab AG