Clinical trials: Medical Device Performance
Vascular Access Device
A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices
The objective of Teleflex's Vascular Access Device Registry (VADER) is to provide high-quality data on the performance, safety, and clinical benefits of Teleflex's vascular access devices when used in a real-world setting
- Trial name
- VADER (NCT06604039)
- Testing
- Central venous catheter
- Where
- 3 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Teleflex
Percutaneous Closure of Arteriotomy in Common Femoral Artery
Safety and Performance Study of Large Hole Vascular Closure Device
The purpose of this Clinical Investigation is to gather feasibility data on the clinical use of the VIVASURE CLOSURE DEVICE™ in relation to safety, and to confirm its performance to percutaneously close femoral arterial puncture…
- Trial name
- FRONTIER-I (NCT01943344)
- Testing
- VIVASURE CLOSURE DEVICE™
- Where
- Ireland
- Volunteers
- 12 people
- Sponsor
- Vivasure Medical Limited
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
Mitral Regurgitation
Observational Study of the Heart Repair Technologies Mitral Bridge in Treating Mitral Valve Regurgitation
Prospective, observational, multi-center trial in which patients with mitral regurgitation sufficient to merit mitral valve repair will receive a surgical transvalvular, intra-annular Mitral Bridge™ to reduce or eliminate mitral…
- Trial name
- HRT (NCT03511716)
- Testing
- HRT Mitral Bridge Mitral Valve Repair
- Where
- Czechia
- Volunteers
- 34 people
- Sponsor
- Heart Repair Technologies, Inc.
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.
Sepsis, Respiratory Failure
Safety, Tolerability and Performance of the NucleoCapture Device in the Reduction of Circulating CfDNA/NETs in Subjects with Sepsis
This is a prospective, multinational, multicentre, randomised, parallel-group, open-label study to assess the safety, tolerability and performance of the NucleoCapture extracorporeal apheresis device in the reduction of…
- Trial name
- NUC-CAP (NCT05647096)
- Testing
- NucleoCapture device
- Where
- 9 sites in Germany, Switzerland and 1 more
- Volunteers
- 73 people
- Sponsor
- Santersus AG
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
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device in Poland
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT02432196
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Sleep Apnea
Evaluation of Compumedics "Somfit" Device
To study whether Somfit is substantially equivalent to an existing approved device (i.e. Compumedic's Grael System) to assist in elucidating sleep disorders.
- Trial name
- NCT04326127
- Testing
- Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Compumedics Limited
COVID-19
Clinical Validation of Breath Analyser Tests for Diagnosis of COVID-19.
The Sponsor has developed a rapid screening tool intended to determine if the subject tested is COVID-19-free (Negative to COVID-19).
- Trial name
- NCT05094674
- Testing
- Breath Sample analysis
- Where
- United Kingdom
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Tera Group
Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2
The BRIGHT Study (Device Name: HALO System)
The purpose of the BRIGHT study is to evaluate safety and performance of the HALO SYSTEM in subjects with diabetes mellitus. The primary objectives of this clinical investigation are 1) the evaluation of sensor's performance by…
- Conditions
- Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Diabetes Mellitus, Ketoacidosis, Diabetic
- Trial name
- NCT07745998
- Testing
- The HALO System
- Volunteers
- 12 people
- Sponsor
- Indigo Diabetes NV
Intracranial Aneurysm
The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System
The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial…
- Trial name
- SUNRISE (NCT00486226)
- Testing
- Vascular Reconstruction Device
- Where
- Belgium
- Volunteers
- 105 people
- Sponsor
- Codman & Shurtleff
Onychomycosis
Single-blind Evaluation of Device to Nail Micro-drilling in Onychomycosis
Based on manufacturer testing, no major difference in drilling condition is expected in this study compared to the drilling conditions previously established.
- Trial name
- NCT00941317
- Testing
- Pathformer (micro-drilling device)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Galderma R&D
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
Gastroesophageal Reflux Disease (GERD)
Study to Evaluate the Performance and Safety of the MARIAL® in Association With PPI Versus PPI Alone
Many patients with acid reflux disease do not improve with regular doses of proton pump inhibitors (e.g., omeprazole). The goals of this clinical trial is the to see if taking MARIAL®, in combination with omeprazole, for one…
- Trial name
- GENYAL® (NCT04130659)
- Testing
- MARIAL® + PPI (generic Omeprazole), PPI alone (generic omeprazole), MARIAL® alone
- Where
- 5 sites in Italy, Romania
- Volunteers
- 110 people
- Sponsor
- Nekkar Lab Srl
Contraception
IUB(TM) SCu300B - Post Marketing Performance Study in Austria
Participating investigators will locate all IUB B insertions conducted at their facility at least 12 month prior the initiation of study data collection. The study is composed of 2 parts.
- Trial name
- NCT02778061
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Ocon Medical Ltd.
Aortic Valve Stenosis
Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV).
- Trial name
- TAB-R (NCT02099942)
- Testing
- V8 Balloon Aortic Valvuloplasty (BAV) Catheter
- Where
- 7 sites in United States
- Volunteers
- 103 people
- Sponsor
- InterValve, Inc.
Chronic Heart Failure
Effect of Enhanced Sweat Rate on the Safety and Edema Status of Chronic Edematous Patients
The purpose of this study is to demonstrate safety and performance of AquaPass System for enhancing fluid transfer through the skin, by increased sweat rate, in edematous patients.
- Trial name
- NCT04578353
- Testing
- The AquaPass System
- Where
- Israel
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- AquaPass Medical Ltd.
Blindness and Low Vision
A Pilot Study Comparing Performance of Blind Participants on 12 Tasks, With and Without the ARIA Device
Summary The environment in which we live, play and travel is primarily built by and for people with sight. Navigating the sighted world with blindness can be exhausting, as it involves disorientation, social isolation, increased…
- Trial name
- NCT06477809
- Testing
- ARIA Glasses ( Augmented Reality in Audio )
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- ARIA Research Pty Ltd
Acute Ischemic Stroke
WOLF - Feasibility Neurothrombectomy Study in Acute Ischemic Stroke Patients
This study is being conducted as a feasibility clinical investigation to collect safety and technical performance data of the WOLF Thrombectomy Device for the removal of thrombus in the neurovasculature.
- Trial name
- WOLF (NCT03781622)
- Testing
- WOLF Thrombectomy Device
- Where
- 2 sites in Canada
- Sponsor
- 880 Medical, LLC