Clinical trials: Safety and Performance
Acute Kidney Failure, Chronic Kidney Diseases
Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients
To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin.
- Trial name
- NCT06358365
- Testing
- The AquaPass System
- Where
- Israel
- Volunteers
- 5 people
- Sponsor
- AquaPass Medical Ltd.
Coronary Artery Disease, Coronary Artery Stenosis
To Evaluate the Performance and Safety of RisoR Crest Everolimus Eluting Coronary Stent System
The study will evaluate the performance and safety of RisoR Crest Everolimus Eluting Coronary Stent System. A total of 2000 participants will be included in the study from India and Italy.
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Percutaneous Coronary Intervention, de Novo Lesions in Native Coronary Arteries
- Trial name
- PACIFIER (NCT07098195)
- Testing
- Coronary Stent
- Volunteers
- 2,000 people
- Sponsor
- Poly Medicure Limited
Lumbar Disc Herniation
Barricaid EU Post Market Study for Primary Lumbar Disc Herniation
The purpose of this multi-center post marketing surveillance study is to monitor the safety and performance of the Barricaid® ARD when used to surgically reconstruct the anulus of the L1 - S1 spinal disc.
- Trial name
- NCT01534065
- Testing
- Barricaid
- Volunteers
- 45 people
- Sponsor
- Intrinsic Therapeutics
Muscle Strength
Investigation of the Efficacy and Safety of Three Test Products and Comparator on Muscular Performance After the Initiation of a Resistance Training Program
The objective of this randomized, triple-blind, comparator controlled, parallel clinical trial is to investigate the functional equivalence of three test products compared to whey protein on muscular performance in a healthy…
- Trial name
- NCT04814225
- Testing
- Test Product 1, Test Product 2, Test Product 3
- Where
- Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Roquette Canada, LTD.
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
Abdominal Aorta Aneurysm
Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position
Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and occlusive disease of the abdominal aorta.
- Trial name
- SYNERGY (NCT01710878)
- Testing
- Intergard Synergy Graft
- Where
- 8 sites in France, Germany
- Volunteers
- 60 people
- Sponsor
- Maquet Cardiovascular
Vaginal Atrophy
Real-world Evidence Study on the Performance and Safety of Halova Ovules
An open-label, multicentric, non-randomized, single-arm, pilot, interventional clinical investigation to confirm the tolerability and performance of the medical device Halova in lubrication of the vagina and vaginal atrophy…
- Trial name
- NCT05654610
- Testing
- Halova
- Where
- 14 sites in Romania
- Volunteers
- 249 people
- Sponsor
- Perfect Care Distribution
Burn Injury, Skin Graft
A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.
Part A The primary objective of Part A will be to verify performance and safety of Mepitel® Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn…
- Trial name
- MpTAg03 (NCT02210208)
- Testing
- Mepitel® Ag, Mepilex® Transfer Ag
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Molnlycke Health Care AB
Gastroesophageal Reflux Disease (GERD)
Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment
This post-market registry aims to assess safety and performance of RefluxStop™ in the treatment of Gastroesophageal Reflux Disease (GERD) in standard of care procedures.
- Trial name
- NCT05870163
- Testing
- RefluxStop implantation, Nissen fundoplication
- Where
- 6 sites in Germany, Italy and 2 more
- Volunteers
- 2,500 people
- Sponsor
- Implantica CE Reflux Ltd.
Artery Stenosis, Carotid, Artery Stenosis
A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch
POLYPATCH® study is RWE multicentre study which examine short and long-term outcomes of using POLYPATCH® when exposed to a larger and more varied population.
- Conditions
- Artery Stenosis, Carotid, Artery Stenosis, Occlusion of Artery, Stroke
- Trial name
- NCT04643743
- Testing
- Endarterectomy
- Where
- France
- Volunteers
- 198 people
- Sponsor
- Perouse Medical
Total Knee Arthroplasty, Knee Disease
Observational Study to Evaluate Clinical Performance and Safety in Total Knee Arthroplasty
The aim of this study is to assess the long-term performance and safety of HLS KneeTec cementless and hybrid fixation knee prosthesis when used in standard medical practice.
- Conditions
- Total Knee Arthroplasty, Knee Disease, Total Knee Replacement, Osteo Arthritis Knee
- Trial name
- NCT04872855
- Testing
- patient with knee arthroplasty
- Where
- 3 sites in France
- Volunteers
- 163 people
- Sponsor
- Corin
Soreness, Muscle, Performance Enhancing Product Use
Acute Study on Muscle Soreness, Damage, and Performance
The acute study will evaluate pre- and post-exercise ingestion of a multi-ingredient supplement in a randomized, double-blind, placebo-controlled, crossover design.
- Conditions
- Soreness, Muscle, Performance Enhancing Product Use, Damage Muscle
- Trial name
- NCT04230226
- Testing
- Pre-workout plus and protein recovery plus
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pharmanex
Healthy
Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer
The purpose of the study is to test the performance and safety of the Bioserenity pulse oxymeter EOXY. For that, and in agreement with ISO60601-2-61 norm and FDA regulation, measures of heart rate, with a gold-standard, and SaO2…
- Trial name
- EOXY (NCT03614416)
- Testing
- EOXY device, Gold standard oximeter, SaO2 sampling
- Where
- Belgium
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- BioSerenity
Acute Kidney Injury
Safety and Performance Evaluation of multiPlus Dialysate During CRRT
Assessment of the performance of multiPlus dialysate based on the serum creatinine removal 6 hours (360 min) after start of continuous veno-venous haemodialysis/ haemodiafiltration [CVVHD(F)].
- Trial name
- multiPlus (NCT05315817)
- Testing
- multiPlus dialysate
- Where
- Germany
- Volunteers
- 1 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Restless Legs Syndrome
Simulated Driving Study in Restless Legs Syndrome
This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS).
- Trial name
- XP083 (NCT01332318)
- Testing
- XP13512, Diphenhydramine
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- XenoPort, Inc.
Liver Resection
Post-Market Clinical Study to Confirm Safety and Performance of PuraStat Absorbable Haemostatic Material for the Management of Bleeding in Liver Surgery
The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.
- Trial name
- NCT03600168
- Testing
- PuraStat®
- Where
- United Kingdom
- Volunteers
- 80 people
- Sponsor
- 3-D Matrix Europe SAS
Total Knee Arthroplasty, Knee Disease
Study to Evaluate Long Term Performance and Safety of the Knee Prosthesis (HLS KneeTec Deep Dish)
The aim of this study is to assess the long-term performance and safety of HLS KneeTec Deep Dish knee prosthesis when used in standard medical practice
- Conditions
- Total Knee Arthroplasty, Knee Disease, Total Knee Replacement, Osteo Arthritis Knee
- Trial name
- NCT05211141
- Testing
- HLS KneeTec Deep Dish
- Where
- France
- Volunteers
- 119 people
- Sponsor
- Corin
Ventricular Tachycardia, Ventricular Fibrillation
Unpinning Termination Therapy for VT/VF
This study is intended to develop a better method for stopping potentially lethal heart rhythms than currently available defibrillators.
- Trial name
- NCT03871231
- Testing
- Unpinning Termination Therapy
- Where
- 4 sites in Australia
- Volunteers
- 8 people
- Sponsor
- Cardialen, Inc.
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
GERD (Heartburn, Regurgitation, and Dyspepsia), Gastroesophageal Reflux (GERD)
A Pre-market, Two-stages Interventional Clinical Investigation to Evaluate the Safety and the Performance of Fibroin Syrup in Reducing the Gastroesophageal Reflux Disease (GERD) Symptomatology in Nonerosive Reflux Disease (NERD) Patients
This study involves a medical device in the form of syrup, not yet on the market and tested for the first time in humans, named "FIBROIN SYRUP".
- Trial name
- NCT07563790
- Testing
- Syrup made by hyaluronic acid
- Where
- Italy
- Volunteers
- 47 people
- Sponsor
- Rose Pharma SA
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