Clinical trials: Device Performance
Bone Augmentation
Evaluation of the Safety and Performance of the Neobone®: A Prospective Observational Study in Dental Area
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neobone® when used according to its intended purpose and current clinical applications.
- Trial name
- NeoDent01 (NCT07179497)
- Where
- Portugal
- Volunteers
- 66 people
- Sponsor
- Bioceramed
Intracranial Aneurysm
Post-Market Clinical Follow-Up Study to Confirm Clinical Performance and Safety of the Codman Enterprise® 2 Vascular Reconstruction Device in the Endovascular Treatment of Intracranial Aneurysms
The objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of the Codman Enterprise® 2 when used in conjunction with endovascular coil embolization of ruptured or non-ruptured…
- Trial name
- SUNRISE-2 (NCT02415010)
- Testing
- Enterprise 2 Vascular Reconstruction Device
- Where
- 10 sites in Germany, Spain and 2 more
- Volunteers
- 26 people
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
Temperature Change, Body, Emergency Department Visit
Performance Study of the Thermodiag Solution for Body Temperature Measurement
The goal of this prospective, comparative, multi-centre interventional clinical investigation, is to evaluate the performance of the Thermodiag® medical device, compared with reference methods, for continuous measurement of core…
- Trial name
- ThermodiagPERF (NCT06703931)
- Testing
- Measures performed on all subjects
- Where
- 4 sites in France
- Volunteers
- 60 people
- Sponsor
- F2D Medical
Post-surgical Oral Wounds, Oral Cavity Surgery
Evaluation of the Performance and Safety of a Linear Hyaluronic Acid-Based Medical Device in the Treatment of Surgical Wounds in the Oral Cavity.
The PR-DENT study is an interventional, single-center, controlled clinical investigation aimed at evaluating the clinical performance and safety of a Class III medical device based on linear hyaluronic acid for the treatment of…
- Conditions
- Post-surgical Oral Wounds, Oral Cavity Surgery, Wound Healing/Regeneration, Dental Extraction Sites
- Trial name
- PR-DENT (NCT07421934)
- Testing
- Intervention: Linear Hyaluronic Acid (Gumblast), Control: Standard Surgical Procedure
- Where
- Italy
- Volunteers
- 28 people
- Sponsor
- The Wave Innovation Group s.r.l.
Gall Bladder Disease, Bile Duct Diseases
AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study
This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips.
- Conditions
- Gall Bladder Disease, Bile Duct Diseases, Acute Cholecystitis, Kidney
- Trial name
- AE05ML (NCT06364865)
- Testing
- laparoscopic procedure
- Where
- 3 sites in United States
- Volunteers
- 161 people
- Sponsor
- Teleflex
NEC
Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird)
Preterm infants are highly vulnerable and may suffer from multiple life-threatening conditions that manifest low tissue oxygenation (StO2).
- Trial name
- (Songbird) (NCT05278247)
- Testing
- NIRS
- Volunteers
- 50 people
- Sponsor
- Carag AG
Wound Heal
Performance, Safety and Efficacy of PICO Device.
The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the…
- Trial name
- NCT03698968
- Testing
- Negative Pressure Wound Therapy
- Where
- 11 sites in Switzerland, United Kingdom
- Volunteers
- 50 people
- Sponsor
- Smith & Nephew, Inc.
Revision of a Shoulder Prosthesis
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder Bipolar System
The study is a monocentric, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study.
- Trial name
- NCT05358574
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Zimmer Biomet
Proximal Humeral Fracture, Proximal Tibia Fractures
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System
The study is a monocentric, retro- and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Zimmer® Plates…
- Conditions
- Proximal Humeral Fracture, Proximal Tibia Fractures, Diaphyseal Fracture
- Trial name
- NCT05215613
- Where
- Italy
- Volunteers
- 57 people
- Sponsor
- Zimmer Biomet
Tachyarrhythmias, Heart Failure
ConsultaTM CRT-D Clinical Evaluation Study
The purpose of the Consulta clinical study is to evaluate the overall system safety and clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D).
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00526162
- Testing
- Bi-ventricular Implantable Cardioverter Defibrillator
- Where
- Germany
- Volunteers
- 83 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Coronary Artery Disease
PMCF Study for Cardiology Access Procedures
This Post-market clinical follow-up (PMCF) study is designed as retrospective, multi-center study to collect real-life data. A multi-center design is used to ensure a representative sample of the physicians who have performed the…
- Trial name
- NCT05543096
- Testing
- Adroit Guiding Catheter, Cordis Transradial Access Devices, Cordis Diagnostic Catheters, Cordis Guidewires
- Where
- 8 sites in Austria, Belgium
- Volunteers
- 200 people
- Sponsor
- Cordis US Corp.
Heart Failure
Safety and Performance Evaluation of CircuLite Synergy
The purpose of the study is to demonstrate the safety and functionality of the CircuLite Synergy Pocket Circulatory Assist Device.
- Trial name
- NCT00878527
- Testing
- CircuLite Synergy Pocket Circulatory Assist Device
- Where
- 11 sites in Belgium, Germany and 3 more
- Volunteers
- 63 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Diabetes Mellitus
Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device
This pivotal multicenter study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.
- Trial name
- NCT04031300
- Testing
- Prototype 0.5
- Where
- 6 sites in Denmark, Germany and 2 more
- Sponsor
- RSP Systems A/S
Skin Aging
Multicenter, Prospective Study to Determine the Performance and Safety of the New M-HA30 Architect Device on the Quality of the Skin: HEBE8 Study
For skin rejuvenation the targeted population does not present a specific pathology. Aesthetic procedures are requested by the patient to improve appearance, look younger and feel better.
- Trial name
- HEBE8 (NCT07007351)
- Testing
- Intradermal injection
- Where
- France
- Volunteers
- 285 people
- Sponsor
- Laboratoires FILLMED
To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB
Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD
The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper.
- Trial name
- NCT02036177
- Testing
- SCu300A IUB intrauterine device, T380A IUD
- Where
- 2 sites in Bulgaria, Romania
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Ocon Medical Ltd.
Atrial Fibrillation, Stroke Prevention
The GLACE Study: Evaluating CLAAS With ICE Guided LAA Closure
The CLAAS® device will be evaluated for safety and performance in the reduction of stroke in subjects with non-valvular atrial fibrillation under intracardiac echocardiography (ICE) imaging for left atrial appendage closure.
- Trial name
- NCT06580275
- Testing
- CLAAS
- Where
- 4 sites in Czechia, Denmark and 1 more
- Volunteers
- 67 people
- Sponsor
- Conformal Medical, Inc
Colorectal Cancer
SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study
A feasibility study to assess the early safety and effectiveness of the Colovac 2 device in providing temporary protection of the anastomosis in patients undergoing low anterior resection for colon cancer.
- Trial name
- NCT06540807
- Testing
- Colovac Colorectal Anastomosis Protection Device, Stoma creation
- Where
- Uzbekistan
- Volunteers
- 24 people
- Sponsor
- SafeHeal Inc
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
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
Burn Wound, Pressure Ulcers Stage II
Study to Evaluate the Performance and Safety of the Medical Device Argogen
A wound, i.e., a break in the skin, can result from several reasons. Pressure ulcers (also called pressure sores, bed sores and decubitus ulcers) are localized damage to the skin and underlying soft tissue usually over a bony…
- Conditions
- Burn Wound, Pressure Ulcers Stage II, Pressure Ulcers Stage III
- Trial name
- NCT05649332
- Testing
- Argogen (silver zeolite powder)
- Where
- 2 sites in Romania
- Volunteers
- 58 people
- Sponsor
- Signorini Medicale S.r.l.