Clinical trials: Safety and Performance
Dental Malocclusion, Edentulous Mouth
Safety and Technical Performance of Plastalgin and Plastalgin Fast in Patients Requiring a Dental Impression
The aim of this study is to gather clinical data related to the use of Plastalgin and Plastalgin Fast, in order to comply with the new medical device regulation.
- Conditions
- Dental Malocclusion, Edentulous Mouth, Dental Misalignment
- Trial name
- NCT05614635
- Testing
- Plastalgin and Plastalgin Fast
- Where
- 2 sites in France
- Volunteers
- 59 people
- Sponsor
- Septodont
Esthetics
Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks
Midface volume loss is a typical sign of facial aging. Age-related loss of subcutaneous fullness in the malar prominence results in a less healthy facial proportion.
- Trial name
- RF-HA-FB-2024 (NCT06915402)
- Testing
- "LMW - CL - HA FACE/BODY
- Where
- Switzerland
- Volunteers
- 26 people
- Sponsor
- Rose Pharma SA
Dry Eye
A Study to Evaluate the Performance and Safety of CBL-102 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
The primary objectives of this investigation were to show that the performance of CBL-102 Eye Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe keratoconjunctivitis sicca after 28 days…
- Trial name
- RESTA (NCT03368404)
- Testing
- CBL-102 eye drops, Vismed Multi eye drops
- Where
- France
- Volunteers
- 92 people
- Sponsor
- Laboratoire Chauvin
Hip Arthropathy, Orthopedic Disorder
Revision LR Femoral Stem for Hip Replacement
This is a post-market, monocentric Retrospective and prospective, observational, open-label and baseline clinical study in order to evaluate the performance and safety of Revision LR femoral stem
- Trial name
- NCT05810584
- Testing
- Revision LR femoral stem
- Where
- Italy
- Volunteers
- 64 people
- Sponsor
- Limacorporate S.p.a
Ischemic Heart Disease
Evaluation of the Palmaz Mach-5 Grooved Bare Metal Coronary Stent System Versus the Palmaz Bare Metal Coronary Stent System in Patients With Symptomatic Ischemic Heart Disease: A Safety and Performance Study
This is a six (6) month, randomized, un-blinded, study to assess the safety and performance of the Palmaz Mach-5 Grooved Coronary Stent System vs. the Palmaz Bare Metal Coronary Stent System.
- Trial name
- NCT02759406
- Testing
- coronary stent
- Volunteers
- 48 people
- Sponsor
- Palmaz Scientific
Onychomycosis of Toenail
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
The objective of this clinical study is to evaluate the performance of URGO MICKAEL Filmogel as a topical treatment for mild to moderate onychomycosis
- Trial name
- MICKAEL (NCT07828184)
- Testing
- URGO MICKAEL Filmogel
- Where
- France
- Volunteers
- 54 people
- Sponsor
- CEN Biotech
Osteoarthritis, Knee, Degenerative Joint Disease of Knee
Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of ORTHIX PLUS
This trial is a post marketing clinical follow up study, aiming to evaluate the performance and safety of ORTHIX PLUS for pain relief in patients suffering from osteoarthritis or degenerative joint diseases.
- Trial name
- NCT05348525
- Volunteers
- 54 people
- Sponsor
- Yooyoung Pharmaceutical Co., Ltd.
Coronary Artery Disease
A Randomized, Double-Blind, Controlled Study of the Safety and Performance of the NIRx™ Paclitaxel-Coated Conformer Coronary Stent
The clinical investigation is an international, prospective, double-blind, randomized safety and efficacy study. The purpose of this study is to evaluate the safety and performance of the NIRx(TM) Paclitaxel-Coated Stent…
- Trial name
- NCT00299026
- Testing
- NIRx(TM) Paclitaxel-Coated Conformer Coronary Stent System
- Where
- Italy
- Volunteers
- 532 people
- Sponsor
- Boston Scientific Corporation
Cartilage Damage
Advanced Cartilage Treatment With Injectable-hydrogel Validation of the Effect
Multicentre, pivotal, non-randomized, prospective, open-label clinical investigation involving a new hydrogel, Hy2Care Injectable hydrogel, developed by Hy2Care B.V., Enschede, The Netherlands (hereafter referred to as "Hy2Care")…
- Trial name
- ACTIVE (NCT05186935)
- Testing
- Injectable Hydrogel treatment
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- Hy2Care BV
Dementia Alzheimer's Type
Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
Primary Objective: To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's disease (AD) while on…
- Trial name
- NCT01266525
- Testing
- SAR110894, Donepezil
- Where
- 82 sites in United States, Australia and 7 more
- Volunteers
- 291 people
- Sponsor
- Sanofi
Abdominal Aortic Aneurysm
Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Abdominal Aortic Aneurysm Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD.
- Trial name
- NCT03687489
- Testing
- Abdominal Aortic Aneurysm Stent Graft System
- Where
- 22 sites in China
- Volunteers
- 156 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Osteoarthritis
ARTEBONE Bone Void Filler in Arthrodesis Procedure of the Ankle
The purpose of this investigation is to assess safety and performance of ARTEBONE Bone Void Filler in the single arthrodesis procedure.
- Trial name
- NCT02480868
- Testing
- ARTEBONE
- Where
- 5 sites in Finland, Poland
- Volunteers
- 34 people
- Sponsor
- BBS-Bioactive Bone Substitutes Oy
Renal Dialysis
Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis
The goal of this prospective, randomized, controlled, cross-over, multicentric study is to demonstrate the safety of bioLogic Fusion in patients on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes.
- Trial name
- NCT06376968
- Testing
- BioLogic Fusion
- Where
- Italy
- Volunteers
- 56 people
- Sponsor
- B.Braun Avitum AG
Pressure Ulcer, Diabetic Foot Ulcer
An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fiber Silver Dressing, When Used in Medium to High Exuding Chronic Wounds
An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds
- Conditions
- Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
- Trial name
- NCT05494450
- Testing
- ExufiberAG+
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Molnlycke Health Care AB
Peripheral Artery Disease (PAD)
A Study to Evaluate the Safety and Effectiveness of the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System in Adults With Peripheral Artery Disease (PAD)
The purpose of this clinical study is to learn if the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System is safe and works well to help people with peripheral artery disease (PAD) who have hard, calcium-filled…
- Trial name
- SPARC (NCT07209085)
- Testing
- FastWave Artero™ Peripheral IVL System
- Volunteers
- 110 people
- Sponsor
- FastWave Medical
Venous Leg Ulcer (VLU)
A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system.
- Trial name
- NCT02167815
- Testing
- Mepilex XT, standard care
- Where
- 3 sites in Czechia
- Volunteers
- 30 people
- Sponsor
- Molnlycke Health Care AB
Bradycardia, Left Bundle Branch Area Pacing
Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum
The purpose of the clinical investigation is to evaluate the safety and performances of the new LINEA cardiac pacing lead, intended for placement at the interventricular septum.
- Conditions
- Bradycardia, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing
- Trial name
- STARLIGHT (NCT07342608)
- Testing
- Use of LINEA cardiac pacing lead
- Where
- 14 sites in Belgium, France and 3 more
- Volunteers
- 450 people
- Sponsor
- MicroPort CRM
Coronary Artery Disease
Study of the Orsiro Drug Eluting Stent System
The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo…
- Trial name
- BIOFLOW-II (NCT01356888)
- Testing
- Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES), Percutaneous Coronary Intervention (Orsiro DES)
- Where
- 24 sites in Austria, France and 6 more
- Volunteers
- 452 people
- Sponsor
- Biotronik AG
Journey II XR Total Knee System
Safety and Performance of Journey II XR Total Knee System
The objective of this study is to estimate the safety and performance of Journey II XR TKS based on retrospective data.
- Trial name
- JIIXR (NCT03798847)
- Testing
- Journey II XR TKA
- Where
- 12 sites in United States
- Volunteers
- 683 people
- Sponsor
- Smith & Nephew, Inc.
Ichthyosis
Patient Study to Evaluate the Safety and Emollient Performance of Doublebase Once in the Treatment of Ichthyosis
28 Day Survey study in patients with Ichthyosis
- Trial name
- NCT07783165
- Testing
- Doublebase Once
- Volunteers
- 100 people
- Sponsor
- Dermal Laboratories Ltd
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