Clinical trials: Device Performance
Trauma Injury, Maxilla Fracture
Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK/MICROTEK®) used for…
- Conditions
- Trauma Injury, Maxilla Fracture, Maxillofacial Trauma
- Trial name
- NCT05742932
- Testing
- Trauma surgery using Global D's implants.
- Where
- 2 sites in France
- Volunteers
- 99 people
- Sponsor
- Global D
Vaginal Disease
Open Non-Comparative Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®
This study evaluates treatment with the medical device Ainara on the improvement of vaginal dryness evaluated by Vaginal Health Index (VHI) and Visual Analog Scale (VAS) in comparison with the baseline condition.
- Trial name
- NCT04245358
- Testing
- Ainara
- Where
- Romania
- Volunteers
- 50 people
- Sponsor
- Italfarmaco
Body Fat
Performance Evaluation of the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat
Clinical Study to Evaluate the Performance the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat
- Trial name
- NCT03433417
- Testing
- Cutera truSculpt
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cutera Inc.
Cardiac Arrhythmia
The Objective of This Multicentre Study is to Collect Operative Data on the Related Clinical Functional Outcomes and Complications and of Market Approved Alcis Electrophysiology Catheters to Demonstrate Safety and Performance of These Devices in a Real-world Setting
The objective of this multicentre study is to collect operative data on the related clinical functional outcomes and complications and of market approved Alcis electrophysiology catheters to demonstrate safety and performance of…
- Trial name
- NCT05314218
- Testing
- Electrophysiology catheters and cables
- Where
- 2 sites in France
- Volunteers
- 168 people
- Sponsor
- Alcis
Unwanted Thigh Fat
UltraShape Device for Thigh Fat and Circumference Reduction vs. Control
UltraShape Device for Thigh Fat and Circumference Reduction: Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive fat and circumference reduction.
- Trial name
- NCT02488083
- Testing
- Ultrashape
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Syneron Medical
Arthroplasty Complications, Infection
Persona Revision Knee System Outcomes
The study will evaluate the performance, clinical benefits and safety of the Persona Revision Knee System in patients who have received primary or revision total knee arthroplasty (TKA) treatment.
- Conditions
- Arthroplasty Complications, Infection, Knee Disease, Knee Osteoarthritis
- Trial name
- NCT04821154
- Testing
- Persona Revision Knee System
- Where
- 16 sites in United States
- Volunteers
- 380 people
- Sponsor
- Zimmer Biomet
Lumbar Disc Herniation, Annular Disc Tear
A Post Marketing Surveillance Study
This study is a prospective, multi-center study to monitor the early safety and performance of one iteration of the Barricaid Anular Closure Device (ACD) - 6mm anchor width, when used as an adjunct to limited discectomy.
- Conditions
- Lumbar Disc Herniation, Annular Disc Tear, Annular Tear of Lumbar Disc
- Trial name
- 6MM (NCT03366779)
- Testing
- 6mm annular closure device
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 20 people
- Sponsor
- Intrinsic Therapeutics
Heart Failure
KV-PREDICT Diagnostic Device in Patients With Heart Failure
This is a pilot, single-center, non-invasive interventional study evaluating the performance of KV-PREDICT, an investigational diagnostic medical device (Class IIa, not CE-marked), in adult patients with heart failure.
- Trial name
- PREDICT_HF (NCT07805213)
- Testing
- KV-PREDICT
- Where
- Italy
- Volunteers
- 120 people
- Sponsor
- KardioVis S.r.l.
Overweight, Obesity
Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.
Study design to demonstrate the safety and performance of the Epitomee Device
- Trial name
- NCT03610958
- Testing
- Epitomee Device
- Where
- Israel
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Epitomee medical
Osteoarthritis, Avascular Necrosis
PMCF Study of the CLS Brevius Stem With Kinectiv Technology
This study is a multi-center, prospective, non-controlled post-market surveillance study. The primary objective of this study is to confirm the safety and performance of the CLS Brevius stem with Kinectiv technology by obtaining…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Femoral Neck Fractures
- Trial name
- NCT03410940
- Testing
- CLS Brevius stem with Kinectiv technology
- Where
- 4 sites in Italy, Poland and 1 more
- Volunteers
- 223 people
- Sponsor
- Zimmer Biomet
Inguinal Hernia
PMCF Study of LiquiBand FIX8® OHMF Device
Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.
- Trial name
- LBF8-Open (NCT04059640)
- Testing
- LiquiBand FIX8 Open Hernia Mesh Fixation Device
- Where
- 3 sites in United Kingdom
- Volunteers
- 109 people
- Sponsor
- Advanced Medical Solutions Ltd.