Clinical trials: Safety and Performance
Mitral Regurgitation, Mitral Insufficiency
Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation
The purpose of the trial is to demonstrate the safety and performance of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery.
- Trial name
- NCT01678144
- Testing
- Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Glenohumeral Osteoarthritis
Performance and Safety of HyalganBio® Intra-Articular Injections as Add-On to Physical Exercise for Symptomatic Glenohumeral Osteoarthritis
This investigation evaluates performance and safety of three intra-articular injections of HyalganBio®, combined with a Physical Exercise Program (PEP) in subjects with glenohumeral osteoarthritis.
- Trial name
- NCT07520708
- Testing
- Hyaluronic acid plus Physical Exercise Program (PEP)
- Where
- 6 sites in Italy
- Volunteers
- 72 people
- Sponsor
- Fidia Farmaceutici s.p.a.
Acute Ischemic Stroke
Safety, Performance of CEREGLIDE 92 Intermediate Catheter in Treatment of Acute Ischemic Stroke
The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease
- Trial name
- SPLENDID (NCT06386289)
- Testing
- Cereglide 92
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
Diffuse Large B Cell Lymphoma, Multiple Myeloma
Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia
Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy.
- Trial name
- PC002 (NCT06323447)
- Testing
- PointCheck
- Where
- 6 sites in United States, Spain
- Volunteers
- 210 people
- Sponsor
- Leuko Labs, Inc.
Kidney Transplantation
Ex Vivo Normothermic Perfusion in Kidney Transplantation.
A multicenter, prospective and open-label clinical investigation to evaluate the viability, performance and safety of ex vivo normothermic perfusion in kidney transplantation from DCD and DBD donors.
- Trial name
- KidneyARK (NCT05175885)
- Testing
- Ex vivo normothermic perfusion, Cold preservation
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Ebers Medical Technology, S.L.
Lung Cancer
Bronchoscopic Microwave Ablation of Lung Tissue
The primary purpose of this study is to evaluate the safety and feasibility of the Creo Medical MicroBlate™ Flex AB1 instrument used with the AB1 electrosurgical system in patients undergoing bronchoscopic microwave ablation of…
- Trial name
- AB1MALT (NCT05786625)
- Testing
- Ablation
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 35 people
- Sponsor
- Creo Medical Limited
Diabetes
A Feasibility Study to Assess Critical Aspects of Fluorescence Affinity Sensor (FAS) Performance and Safety Over Several Hours
The goal of this clinical research study is to learn about a new minimally invasive glucose monitoring device called Fluorescence Affinity Sensor (FAS).
- Trial name
- FAS (NCT01065948)
- Testing
- Subcutaneous glucose monitoring device
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- BioTex, Inc.
Dental Caries
Safety and Performance Evaluation of the Calcivis System
This is a prospective, multi-centre clinical study to evaluate the safety and performance of the Calcivis Caries Activity Imaging System.
- Trial name
- NCT02780856
- Testing
- Imaging with the Calcivis System
- Where
- 4 sites in United Kingdom
- Volunteers
- 110 people
- Sponsor
- Calcivis Ltd
Gastrointestinal Cancer
Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran® 2 Usability Trial in EMR and ESD
The aim of this single-center study is to evaluate the feasibility of the technique, usability and safety of the device ENDONEB.
- Trial name
- NCT06588881
- Testing
- nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection
- Where
- Italy
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GEM SRL
Aortic Dissection Type B
Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection
A prospective, multi-center, objective performance criteria clinical trial to evaluate the safety and efficacy of Fabulous Stent Graft System manufactured by Hangzhou Endonom Medtech Co., Ltd. for Stanford B Aortic Dissection.
- Trial name
- NCT04918212
- Testing
- Fabulous Stent Graft System
- Where
- 24 sites in China
- Volunteers
- 148 people
- Sponsor
- Hangzhou Endonom Medtech Co., Ltd.
Peripheral Arterial Vascular Occlusion
dCell Vascular Patch in Peripheral Vascular Surgery Study for CE Mark Submission
The study is designed to produce early safety and performance data in a small group of patients requiring repair of a peripheral vascular endarterectomy (incision into an artery feeding the limbs which requires a patch to repair…
- Trial name
- NCT00958230
- Testing
- dCell Vascular Patch
- Where
- 4 sites in Hungary, Netherlands
- Volunteers
- 21 people
- Sponsor
- Tissue Regenix Ltd
Bacterial Vaginosis
Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis
The aim of this study is to find out how well the medical device Lactal Gel works and how safe it is. The product will be used to treat bacterial vaginosis in a group of fifty women aged 18 years or older.
- Trial name
- NCT07241871
- Testing
- Lactal Gel (Class IIa medical device)
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Rolf Kullgren AB
Diabetes Mellitus, Healthy
Reconfirming the Safety and Performance of the Glyconics-DS System in Known Populations With and Without Diabetes
A single-site, open label, confirmatory study assessing two biomarkers indicative of levels of glycaemia; glycated keratin in fingernails and glycated haemoglobin (HbA1c). Screening for diabetes
- Trial name
- ANODE04 (NCT07039357)
- Testing
- Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail
- Where
- 2 sites in United Kingdom
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Glyconics Ltd
Lip Augmentation
A Study to Evaluate the Safety and Performance of Dr Korman Laboratories' Hyaluronic Acid Filler 20 mg/mL With Lidocaine for Lip Augmentation
This study will assess the safety and effectiveness of a dermal filler called DKL crosslinked hyaluronic acid 20 mg/mL with lidocaine 0.3% when injected into the lips of healthy men and women who want to have fuller lips.
- Trial name
- NCT07204691
- Testing
- DKL crosslinked sodium hyaluronate 20 mg/mL + Lidocaine 0.3% dermal filler
- Where
- 2 sites in Sweden
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Dr. Korman Laboratories Ltd.
Bone Regeneration
Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
Guided Bone Regeneration (GBR) is a well-established surgical technique that employs barrier membranes to ensure the stability of bone augmentation material while preventing the infiltration of soft tissue, thereby facilitating…
- Trial name
- LyOral (NCT06732167)
- Testing
- GBR Lyoplant, GBR Bio-Gide
- Where
- 2 sites in Spain
- Volunteers
- 68 people
- Sponsor
- Aesculap AG
Dry Eye
A Study to Evaluate the Performance and Safety of CBL-101 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
The primary objectives of this investigation are to show that the performance of CBL-101 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
- NCT02975102
- Testing
- CBL-101 Eye Drops, Vismed® Multi Eye Drops
- Where
- 2 sites in Belgium, France
- Volunteers
- 87 people
- Sponsor
- Laboratoire Chauvin
Urinary Incontinence, Urge Incontinence
UCon Treatment of Overactive Bladder (OAB) in Males
UCon is a medical device for treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired…
- Conditions
- Urinary Incontinence, Urge Incontinence, Nocturia, Urinary Frequency More Than Once at Night
- Trial name
- NCT05874375
- Testing
- Urge stimulation, Time limited stimulation
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- InnoCon Medical
Healthy, ECG
Evaluation of CSF-3 in Performing ECG
CSF-3 is a wrist-worn medical device similar to a watch. It is designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings, using off-the-shelf ECG and unique PPG chipsets with…
- Trial name
- ECG (NCT05591157)
- Testing
- CSF-3 watch, designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- CardiacSense Ltd.
Fractures of the Long Bones, Vertically Stable Pelvic Fractures
Observational Study for the Evaluation of the Clinical Performance and Safety Profile of the GALAXY FIXATION™ System and Orthofix Implantable Devices: GALAXY Study
The GALAXY FIXATIONTM System and Orthofix implantable devices study intends to evaluate the clinical performance and safety profile of the study medical/investigational devices in the standard clinical practice.
- Conditions
- Fractures of the Long Bones, Vertically Stable Pelvic Fractures, Vertically Unstable Pelvic Fractures
- Trial name
- NCT06690437
- Testing
- Galaxy Fixation System and Orthofix implantable devices
- Where
- 3 sites in Italy
- Volunteers
- 3 people
- Sponsor
- Orthofix s.r.l.
Esthetics
An Open, Non-comparative, Single-centre Post Marketing Clinical Followup (PMCF) Investigation to Evaluate Performance and Safety of the ALIAXIN Fillers Used as Intended
This is an open, non-comparative, Single-centre Post Marketing Clinical Followup (PMCF) study aimed to enrol patients with medium and deep facial sagging, facial volume defects and/or lips volume and contours defects.
- Trial name
- NCT05808205
- Testing
- • ALIAXIN EV: Essential Volume • ALIAXIN FL: Lips • ALIAXIN SR: Shape & Restore • ALIAXIN GP: Global Performance • ALIAXIN LV: Lips Volume
- Where
- Italy
- Volunteers
- 350 people
- Sponsor
- Rose Pharma SA
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