Clinical trials: Safety and Performance
Coronary Artery Diseases
BIOFLOW III Satellite-Italy Orsiro Stent System
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.
- Trial name
- NCT02028728
- Where
- 18 sites in Italy
- Volunteers
- 609 people
- Sponsor
- Biotronik Italia S.p.A.
RDS of Prematurity, Preterm Birth
Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Pivotal study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Trial name
- NCT07060911
- Testing
- Lung monitoring with the Neola device
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Neola Medical Inc
Vascular Closure, Femoral Arteriotomy Closure
The Ladera Large Bore Closure Feasibility Study
This study evaluates the safety and performance of the Ladera Medical suture-mediated large bore closure (LBC) system in gaining post procedure hemostasis in subjects undergoing interventional catheterization procedures using a…
- Trial name
- NCT06358157
- Testing
- Ladera LBC System
- Where
- 3 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Ladera Medical
Heart Failure
A Clinical Trial to Evaluate the HeartWare MVAD® System (MVAdvantage)
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart…
- Trial name
- NCT01831544
- Testing
- HeartWare MVAD® System
- Where
- 11 sites in Australia, Austria and 3 more
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region
Aequalis Resurfacing Head Study
Aequalis® Resurfacing Head implant is a range of shoulder arthroplasty device available for the treatment of various shoulder pathologies. It received CE Mark in June 2007.
- Conditions
- Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Avascular Necrosis of the Head of Humerus
- Trial name
- NCT02444299
- Testing
- Shoulder hemi-arthroplasty
- Volunteers
- 100 people
- Sponsor
- Stryker Trauma and Extremities
Bacterial Vaginosis
A Randomised, Partly-blinded Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Bacterial Vaginosis Compared With an Untreated Control Group
This is a randomised, parallel group, partly blinded investigation to evaluate the clinical performance and safety of pHyph in adult women with bacterial vaginosis.
- Trial name
- Nefertiti 2 (NCT06123299)
- Testing
- pHyph
- Where
- 5 sites in Sweden
- Volunteers
- 61 people
- Sponsor
- Gedea Biotech AB
Nasolabial Folds, Wrinkles
A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds
This is a prospective, randomized, controlled clinical investigation designed to evaluate the performance and safety of DMFI300 for the treatment of nasolabial folds.
- Trial name
- NCT07467239
- Testing
- DMFI300, Ellansé-M
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Samyang Biopharmaceuticals Corporation
Healthy Subjects
JetTouch Injection System to Deliver Saline Into the Bladder Wall of Healthy Volunteers
This research study is being done to see how well the JetTouch Needle-Free Endoscopic Injection System is able to deliver a solution safely into the bladder wall.
- Trial name
- NCT01862601
- Testing
- JetTouch Needle-free injection system
- Where
- 2 sites in United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- American Medical Systems
Cochlear Hearing Loss
Safety and Performance of HiRes Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss
This is a prospective study designed to evaluate the safety and performance of the HiRes Ultra Cl HiFocus MS Electrode and HiRes Ultra 3D Cl HiFocus MS Electrode (Ultra X) under normal conditions of use as it is approved for this…
- Trial name
- NCT04610112
- Testing
- Cochlear implantation
- Where
- 3 sites in Germany
- Volunteers
- 30 people
- Sponsor
- Advanced Bionics AG
Multiple Myeloma, Solitary Plasmacytoma
MargheRITA (Remote Intelligence for Therapeutic Adherence)
It is essential to improve clinical efficiency and management of hematological and oncological patients treated on an outpatient basis.
- Conditions
- Multiple Myeloma, Solitary Plasmacytoma, Amyloidosis, Chronic Myeloid Leukemia
- Trial name
- MargheRITA (NCT05260203)
- Testing
- RITA (App)
- Where
- Italy
- Volunteers
- 124 people
- Sponsor
- Advice Pharma Group srl
Contraception: Optional Applicator for Insertion of Vaginal Ring
Performance and Safety of Vaginal Ring Applicator in Healthy Females (MK-8342A-063)
The purpose of the study is to assess the performance and safe use of the vaginal ring applicator as an optional aid for insertion of a placebo vaginal ring into the vagina in healthy women
- Trial name
- NCT02275546
- Testing
- Single-use, non-sterile applicator
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Surgery, Central Line Associated Blood Stream Infections (CLABSI)
BIP CVC Clinical Safety and Performance Study
The primary objective of this trial was to determine Bactiguard coated BIP CVC's safety and performance and compare it to corresponding standard uncoated CVC.
- Trial name
- NCT02811380
- Testing
- BIP CVC, Uncoated Standard CVC
- Where
- Sweden
- Volunteers
- 36 people
- Sponsor
- Bactiguard AB
Abdominal Injury, Thoracic Diseases
A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.
The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days…
- Trial name
- NCT03515811
- Testing
- Signia™ Stapling System
- Where
- 11 sites in United States, Canada and 3 more
- Volunteers
- 136 people
- Sponsor
- Medtronic - MITG
Large Hole Percutaneous Arterial Closure
Safety and Performance Study for Arterial Large Hole Vascular Closure Device
To study will assess safety and performance of the PerQseal Elite Closure Device when used with the 18F PerQseal Elite Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients…
- Trial name
- ELITE (NCT05951634)
- Testing
- PerQseal ELITE
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Vivasure Medical Limited
Ventricular Arrythmia, Lead
Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)
The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR)
- Conditions
- Ventricular Arrythmia, Lead, ICD, Heart Failure
- Trial name
- APOLLO (NCT04590144)
- Testing
- INVICTA lead
- Where
- 45 sites in Austria, France and 6 more
- Volunteers
- 446 people, healthy volunteers welcome
- Sponsor
- MicroPort CRM
Hemostasis
Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery.
- Trial name
- NOBLE-Open (NCT03873168)
- Testing
- HEMOBLAST™ Bellows
- Where
- 9 sites in Austria, France and 1 more
- Volunteers
- 64 people
- Sponsor
- Biom'Up France SAS
Aortic Valve Disease
Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve…
- Trial name
- CENTERA-1 (NCT01808274)
- Testing
- Edwards CENTERA Self-Expanding Transcatheter Heart Valve
- Where
- 4 sites in Germany, Switzerland
- Volunteers
- 34 people
- Sponsor
- Edwards Lifesciences
Urinary Lithiasis
Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent
The goal of this clinical investigation is to evaluate whether the Hydrustent® medical device is safe and if maintain the urinary flow inside the ureter in adults.
- Trial name
- Hydrustent (NCT06719089)
- Testing
- Biodegradable double loop ureteral stent, PolyUrethane Double Loop Ureteral Stent
- Where
- 4 sites in Portugal
- Volunteers
- 134 people
- Sponsor
- Hydrumedical
Femoropopliteal In-Stent Restenosis
First in Human Study of Winsor Laser Catheter: A Prospective Registry to Evaluate The Safety and Performance of the Winsor Laser Catheter in the Treatment of In-Stent Restenosis
The study will evaluate the procedural safety and efficacy of the Winsor Laser Catheters for the treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
- Trial name
- NCT01962389
- Testing
- Winsor Laser Catheter
- Where
- Colombia
- Sponsor
- Spectranetics Corporation
Diabetic Foot Ulcer, Venous Leg Ulcer
ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds
We are testing a gel intended for the protection and healing of chronic wounds as a support for standard therapy. The main component of the gel is chitosan, a natural polymer that has the ability to stop bleeding, has a positive…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Trial name
- CHITOCHRONIC (NCT05570877)
- Testing
- ChitoCare medical Wound Healing Gel
- Where
- 9 sites in Croatia, Slovenia
- Volunteers
- 92 people
- Sponsor
- Primex ehf
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