Clinical trials: Device Performance
Combined Point of Care Diagnostic of HIV, HBV and HCV
Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV…
- Trial name
- MAGICIEN (NCT06082336)
- Testing
- MagIA IBC test in capillary blood, MagIA IBC test in other blood matrices
- Where
- 2 sites in France
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- MagIA Diagnostics
Prolapse; Female
Evaluation of the Safety, Performance, and Tolerability of the Sacromesh® Medical Device in the Treatment of Prolapse by Promontofixation in a Population of Patients Followed Over the Long Term.
An observational, multicenter study with retrospective recruitment and two data collection methods, one retrospective (medical records) and the other prospective (questionnaires).
- Trial name
- SCUPP (NCT06620211)
- Testing
- promontofixation, prolapse cure
- Where
- France
- Volunteers
- 290 people
- Sponsor
- Cousin Biotech
Acute on Chronic Liver Failure
Safety and Performance Trial of DIALIVE Liver Dialysis Device in Acute On Chronic Liver Failure Patients
The First-In-Man study is a multi-centre, randomised, controlled, study to generate data for the evaluation of safety and performance of DIALIVE Liver Dialysis Device in 24 evaluable patients with Acute on Chronic Liver Failure…
- Trial name
- DIALIVE _ACLF (NCT03065699)
- Testing
- DIALIVE Liver Dialysis Device
- Where
- 12 sites in Austria, Belgium and 6 more
- Volunteers
- 30 people
- Sponsor
- Yaqrit Ltd
Age-related Cataract, Vision Loss
Long-term Safety & Performance of REVISYON SDS100 in Mild to Moderate Cataract: Extension Study (EB-CE-02)
A non-interventional, extension study on the long-term maintenance of safety and performance of the REVISYON SDS 100 medical device in subjects with mild-to-moderate cataract.
- Conditions
- Age-related Cataract, Vision Loss, Cataract, Mild Cataract
- Trial name
- EB-CE-02 (NCT07246915)
- Where
- 6 sites in Romania
- Volunteers
- 47 people
- Sponsor
- Edinburgh Biosciences Ltd
Rheumatoid Arthritis, Non-inflammatory Degenerative Joint Disease
PMCF Study on the Safety, Performance and Clinical Benefits Data of the NexGen TM Augmentation Patella
The study is a single-center, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study.
- Conditions
- Rheumatoid Arthritis, Non-inflammatory Degenerative Joint Disease, Functional Deformity, Revision Total Knee Arthroplasty
- Trial name
- NCT05253976
- Where
- Switzerland
- Sponsor
- Zimmer Biomet
Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices.
- Conditions
- Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis, Hip Arthritis, Femoral Neck Fractures
- Trial name
- NCT05227924
- Testing
- Total hip arthroplasty (primary or revision)
- Where
- 9 sites in France
- Volunteers
- 747 people
- Sponsor
- Dedienne Sante S.A.S.
Bowel Dysfunction
En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device.
This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the…
- Trial name
- NCT06377280
- Testing
- Navina Mini
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- Wellspect HealthCare
Vascular Access Complications
Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters.
- Trial name
- NCT01940354
- Testing
- AccuCath IV Catheter System, Conventional IV Catheter System
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
Low Back Pain
Evaluation of the Japet.W+ Medical Device for Low Back Pain Management
The JAPET.W+ medical device is a new dynamic distraction support system. It could be considered as a new solution in the therapeutic arsenal for managing common low back pain.
- Trial name
- EXODOMICILE (NCT07195422)
- Testing
- Japet.W+, Control (Standard treatment)
- Where
- 2 sites in France
- Volunteers
- 102 people
- Sponsor
- Japet Medical Devices
Flanks Fat Reduction vs. Control
Fat Reduction in the Flanks Area vs. Control
Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation the performance of the UltraShape treatment for non-invasive fat reduction by compare control and treated flanks.
- Trial name
- NCT02465775
- Testing
- UltraShape treatment
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Syneron Medical
Spinal Disorders/Injuries
A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
This protocol is designed to study Orthofix regulatory approved and commercially available spine devices to generate Real World Evidence (RWE) of device safety and performance in the treatment of patients with spine injuries…
- Trial name
- RWE Spine (NCT05082090)
- Testing
- Spinal Surgery
- Where
- 20 sites in United States, Germany and 2 more
- Volunteers
- 2,000 people
- Sponsor
- Orthofix Inc.
Vascular Access Complication
AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and…
- Trial name
- NCT01943474
- Testing
- AccuCath IV Catheter Device, Conventional IV Catheter Device
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- C. R. Bard
Hepatic Tumor
Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.
- Trial name
- NCT04230642
- Testing
- The Quantum Surgical device
- Where
- 2 sites in France
- Volunteers
- 22 people
- Sponsor
- Quantum Surgical
Acute Upper Gastrointestinal Hemorrhage, Acute Upper Gastrointestinal Bleeding
Clinical Investigation of Safety and Performance of a Medical Device (ClearPlasma) for the Treatment of Patients With Acute Upper Gastrointestinal Hemorrhage.
Pre-market, multi-center, international, double-blind, randomized, controlled, prospective, first-in-human clinical investigation of a Class IIb Investigational Medical Device, in which Patients presenting with acute upper…
- Trial name
- NCT04174989
- Testing
- Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device), Regular fresh-frozen plasma (not treated)
- Where
- 8 sites in Czechia, Israel and 1 more
- Volunteers
- 53 people
- Sponsor
- PlasFree Ltd.
Atrial Fibrillation
Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
- Trial name
- PULSE-EU (NCT05164107)
- Testing
- Globe Mapping and Pulsed Field Ablation System (Globe PF System)
- Where
- Czechia
- Volunteers
- 175 people
- Sponsor
- Kardium Inc.
Prostate Cancer
Performance Evaluation of the AMS CONTINUUM™ Device
1. To assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy. 2.
- Trial name
- NCT00894933
- Testing
- CONTINUUM™
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- American Medical Systems
Rheumatoid Arthritis
The SetPoint System Safety & Performance Post-Approval Study
Prospective, multicenter, post-market, registry study designed to systematically collect real-world data (RWD) from participants implanted with the SetPoint System [implanted, vagus-mediated, neuroimmune modulator] for the…
- Trial name
- ACTIVATE (NCT07489326)
- Testing
- SetPoint System
- Volunteers
- 150 people
- Sponsor
- SetPoint Medical Corporation
Polyp, Colorectal
Colorectal Polyp Clinical Decision Support Device Study
The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.
- Conditions
- Polyp, Colorectal, Colonoscopy
- Trial name
- CDSD (NCT04437615)
- Testing
- Colonoscopy, Clinical Decision Support Device
- Where
- United States
- Volunteers
- 2,379 people
- Sponsor
- Olympus Corporation of the Americas
Cervical Cytology, PAP
Techcyte SureView Cervical Cytology System Clinical Validation Study
The clinical study is a multi-center, retrospective, blinded, matched-pair, two-arm clinical study in which one test assessment and a control assessment of liquid-based cytology (LBC) pap tests are performed and compared to a…
- Trial name
- NCT06767111
- Testing
- Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm in vitro diagnostic (IVD) device
- Where
- United States
- Volunteers
- 4,596 people, healthy volunteers welcome
- Sponsor
- Techcyte, Inc.
Degenerative Disc Disease, Degenerative Spondylolisthesis
Lumbar Interbody Implant Study
The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis
- Trial name
- NCT04418830
- Where
- 16 sites in United States
- Volunteers
- 1,050 people
- Sponsor
- NuVasive