Clinical trials: Safety and Performance
Leg Ulcer, Pressure Ulcer (PU)
Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears
This post-market clinical follow-up investigation is designed to evaluate the performance and safety of Mepilex® Up when used for the management of exuding ulcers and skin tears on the leg and foot.
- Conditions
- Leg Ulcer, Pressure Ulcer (PU), Skin Tears, Foot Ulcer
- Trial name
- NCT07782008
- Testing
- Mepilex® Up
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Molnlycke Health Care AB
Diseased or Occluded Blood Vessels, Arteriovenous Shunting for Blood Access
LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry
This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search.
- Trial name
- NCT04620889
- Testing
- AV Access, PVP
- Where
- Germany
- Volunteers
- 153 people
- Sponsor
- LeMaitre Vascular
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry
The BIOFLOW-VIII registry is a post-market clinical evaluation of the Orsiro Mission stent in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Trial name
- BIOFLOW-VIII (NCT04555174)
- Testing
- Orsiro Mission DES
- Where
- 41 sites in France
- Volunteers
- 872 people
- Sponsor
- Biotronik AG
Urinary Incontinence, Urinary Incontinence, Urge
Safety and Performance of UCon Patch Electrode
UCon is a medical device for treating the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behavior of the bladder/bowel musculature e.g.…
- Conditions
- Urinary Incontinence, Urinary Incontinence, Urge, Nocturia, Urinary Frequency More Than Once at Night
- Trial name
- NCT06754189
- Testing
- Time Limited stimulation
- Where
- 3 sites in Denmark
- Volunteers
- 180 people
- Sponsor
- InnoCon Medical
Primary Open Angle Glaucoma, Pigmentary Glaucoma
Minimally Invasive Micro Sclerostomy First in Man Safety and Preliminary Performance Study
The study objective is to demonstrate the safety of Minimally Invasive Micro Sclerostomy (MIMS) device for lowering elevated IOP in patients diagnosed with glaucoma.
- Conditions
- Primary Open Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliative Glaucoma
- Trial name
- NCT02355990
- Testing
- Minimally Invasive Micro Sclerostomy
- Where
- Israel
- Volunteers
- 96 people
- Sponsor
- Sanoculis Ltd
Chronic Total Occlusion of Coronary Artery
A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter
This is a prospective, non-randomized, first-in-man investigational study, to assess the safety and technical feasibility, deployment and withdrawal characteristics of the NovaCross™ micro-catheter during an interventional…
- Trial name
- NCT01978860
- Testing
- NovaCross, CTO
- Where
- Israel
- Volunteers
- 2 people
- Sponsor
- Chanan Schneider
Myopia
Performance and Safety of Silicone Hydrogel Soft Contact Lenses
To demonstrate substantial equivalence of the new Silicone Hydrogel Soft Contact Lenses(SHSCL) to the commercially available ACUVUE® VITA™ contact lens
- Trial name
- NCT04226560
- Testing
- 41% Silicone Hydrogel Soft Contact Lenses(SHSCL), ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens, Contact Lens Care Product
- Where
- Taiwan
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- ApexLens Co., Ltd.
AAT9
Further Evaluation of Safety and Performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS Multibranch™ Aortic Arch Stent Graft System
The goal of this observational study is to collect clinical information on how safe, and how well the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System work for the treatment of…
- Trial name
- ARCUS (NCT05636527)
- Where
- 18 sites in Belgium, Cyprus and 8 more
- Volunteers
- 70 people
- Sponsor
- Endospan Ltd.
Breast Asymmetry Between Native Breast and Reconstructed Breast
Performance of OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation
This is a Phase IV, multicenter, open label, non-randomized comparative group study to assess the safety and performance of the OrbiSymm system in subjects referred to contra lateral breast symmetrization involving a breast…
- Trial name
- NCT02649283
- Testing
- OrbiSymm device, Breast symmetrisation
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Orbix Medical Ltd.
Dental Prosthesis
Observational Study Evaluating Safety and Performance of IDI Dental Implant Systems in Subjects Followed for 18 Months.
Post-Market Clinical Follow-Up to evaluate the safety and performance of IDI dental implant systems : confirmation of osseointegration of the different implants at the loading visit (between 2 and 6 months after surgery).
- Trial name
- NCT05130996
- Testing
- dental prothesis
- Where
- France
- Volunteers
- 121 people
- Sponsor
- Implants Diffusion International
Vascular Diseases
First In-human Use of SETALUM™ Sealant: The BlueSeal Clinical Study
This is a prospective, multicenter, single-arm trial to evaluate the safety and performance of SETALUM™ Sealant in sealing suture lines at the anastomosis between native vessels and synthetic ePTFE vascular patch used during open…
- Trial name
- NCT03374735
- Testing
- SETALUM™ Sealant
- Volunteers
- 22 people
- Sponsor
- Gecko Biomedical
Abdominal Aortic Aneurysm
ARBITER-II: Aorfix™ Bifurcated Safety and Performance Trial: Phase II, Angulated Vessels
To assess the safety and performance of Aorfix™ Stent Grafts in the treatment of Abdominal Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel angulation exists at the neck of the aneurysm or in the common iliac…
- Trial name
- ARBITER-II (NCT00442065)
- Testing
- Aorfix™ Stent Grafts (AAA endovascular procedure)
- Where
- 6 sites in Czechia, Germany and 3 more
- Volunteers
- 30 people
- Sponsor
- Lombard Medical
Wound Heal
A Retrospective, Observational Study of the Real-world Safety and Performance of InnovaMatrix® AC at a Single Centre
The use of a decellularised porcine placental extracellular matrix in hard-to-heal wounds: A retrospective study of the real-world performance of InnovaMatrix® AC at a single centre.
- Trial name
- NCT07170566
- Testing
- innovaMatrix AC
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- ConvaTec Inc.
Solid Tumor
A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors
This Phase I/II clinical study, titled "A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors", aims to evaluate the safety and diagnostic performance of F18 FBPA PET/CT imaging in…
- Trial name
- NCT07691775
- Testing
- F18 FBPA Injection
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Heron Neutron Medical Corp.
ACL Rupture
Clinical Performance and Safety of ENDOPACK® DT4-EBMCA in ACL Reconstruction 24 Months Post-surgery
Anterior cruciate ligament (ACL) injuries are among the most common sports-related knee traumas. The DT4-EBMCA device, based on a quadrupled semitendinosus autograft technique, aims to provide effective and minimally invasive…
- Trial name
- DT4-EBMCA (NCT06990100)
- Testing
- ACL surgery
- Where
- France
- Volunteers
- 36 people
- Sponsor
- SACIMEX
Transfusion Reaction
Clinical Performance Study of Safety Test ABO Device
The study aims to confirm the performance equivalence of the in vitro diagnostic device Safety Test ABO with the ABTest Card device.
- Trial name
- NCT06543771
- Testing
- Safety Test ABO and ABTest Card®
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Diagast
Cataract
Cataract Surgery: Femto LDV Z8 Versus Conventional
The aim of the study is to demonstrate the performance and safety of the Femtosecond laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV Z8 compared to conventional technique in cataract…
- Trial name
- COMFORT (NCT02351271)
- Testing
- Femto LDV Z8, Manual capsulorhexis&lens fragmentation
- Volunteers
- 130 people
- Sponsor
- Ziemer Ophthalmic Systems AG
Acute Ischemic Stroke, Large Vessel Occlusion
Evaluation of the CONDA Stent Retriever in Acute Ischemic Stroke
The goal of this study is to evaluate the safety and performance of the CONDA stent retriever in patients with acute ischemic stroke due to large vessel occlusion, treated within 24 hours of symptom onset.
- Trial name
- ARTEMIS (NCT07174505)
- Testing
- Mechanical Thrombectomy using the CONDA Stent Retriever
- Where
- 2 sites in Hungary, Spain
- Volunteers
- 50 people
- Sponsor
- Anaconda Biomed S.L.
Chronic Idiopathic Constipation
Performance, Efficacy and Safety of Vibrating Capsule in Aiding Constipated Individuals
This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated Individuals
- Trial name
- NCT02030756
- Testing
- vibrating capsule
- Where
- 18 sites in United States, Israel
- Volunteers
- 144 people
- Sponsor
- Vibrant Ltd.
Hearing Loss
The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents
This study is a post-market, multicentre, prospective, single arm investigation aimed to systematically collect safety and performance data on the Sentio system, when used as intended for adolescents (12-17 years inclusive).
- Trial name
- NCT06844071
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Oticon Medical
The first 1,020 results can be paged through. Add a filter or change the sort order to reach the rest.