Clinical trials: Demonstrate Effectiveness of Virtual Simulator in Improving or Performance
- Condition Demonstrate Effectiveness of Virtual Simulator in Improving or Performance
- Funder type Industry (pharma, biotech, devices)
Screening Colonoscopy for Low Risk Subjects
First in Man Aer-O-Scope
A single center study intended to evaluate the Aer-O-Scope Colonoscope System.
- Trial name
- NCT02102412
- Testing
- screening colonoscopy
- Where
- Croatia
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- GI View Ltd.
Radiation Therapy
CLARITY Study - PMCF Study
In the context of the Post-Market Clinical Follow-up (PMCF), this study aimed at evaluating the safety and performance of the RADSAFE® inks in the marking of the radiation field.
- Trial name
- NCT06854263
- Testing
- skin marking for radiotherapy treatment
- Volunteers
- 119 people
- Sponsor
- Laboratoires BIOTIC Phocea
Blood Stream Infection, Blood Stream Infections
Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
This study is designed to evaluate the clinical performance of the UllCORE Bloodstream Infection (BSI) Test, an investigational molecular diagnostic test intended to detect microorganisms and selected antimicrobial resistance…
- Conditions
- Blood Stream Infection, Blood Stream Infections, Sepsis, Fungemia
- Trial name
- B-RAPID (NCT07859852)
- Testing
- UllCORE BSI Test
- Where
- 20 sites in United States, France and 3 more
- Volunteers
- 1,500 people
- Sponsor
- Deepull Diagnostics S.L.
Blood Coagulation Disorders
ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals
ROTEM® sigma is a new thromboelastometric coagulation analysis system. The new system is fully automated allowing for a simple and safe operation compared to its predecessor model ROTEM® delta.
- Trial name
- ROSI-EVA (NCT02379104)
- Testing
- ROTEM sigma
- Where
- 5 sites in United States, Austria and 1 more
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Tem Innovations GmbH
Venous Leg Ulcer (VLU)
A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system.
- Trial name
- NCT02167815
- Testing
- Mepilex XT, standard care
- Where
- 3 sites in Czechia
- Volunteers
- 30 people
- Sponsor
- Molnlycke Health Care AB
Ventricular Tachycardia (VT)
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the…
- Trial name
- NCT06703489
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Bloodstream Infection
Reduction of Pathogen Load From the Blood in Septic Patients With Suspected, Life-threatening Bloodstream Infection
Safety and Performance Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream infection
- Trial name
- NCT04260789
- Testing
- Seraph 100,The Microbind Affinity Blood Filter
- Where
- 25 sites in Austria, Belgium and 7 more
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- ExThera Medical Europe BV
Aneurysm Arterial, Peripheral Arterial Disease
Safety and Performance of POLYTHESE® Vascular Prosthesis
POLYTHESE® study is a retrospective, observational, multicentre, case series which examine short and long-term outcomes of using POLYTHESE®.
- Conditions
- Aneurysm Arterial, Peripheral Arterial Disease, Marfan Syndrome, Arterial Dissections
- Trial name
- NCT05516043
- Testing
- Implantation with POLYTHESE®
- Where
- 3 sites in France
- Volunteers
- 256 people
- Sponsor
- Perouse Medical
Cataract, Pseudophakia
Clinical Investigation of the Safety and Performance of Model 690AD and Model 690ADY Monofocal Intraocular Lens Implantation
Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOLs) are indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline…
- Conditions
- Cataract, Pseudophakia, Intraocular Lens Complication, Intraocular Lens Opacification
- Trial name
- NCT05750225
- Testing
- Standard of care, Patient satisfaction questionnare
- Where
- 2 sites in Hungary
- Volunteers
- 52 people
- Sponsor
- Medicontur Medical Engineering Ltd
Colostomy
One Piece Closed Pouch in Subjects With a Colostomy
A study to assess the safety and performance of an enhanced one piece closed pouch in a 12 subjects with a colostomy.
- Trial name
- NCT01935999
- Testing
- One piece closed pouch
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- ConvaTec Inc.
Resting Metabolic Rate, Energy Metabolism
Observing Performance of Haptic Vibrotactile Trigger Technology by Measuring Changes in Resting Metabolic Rate: Assessment and Analysis
This study evaluates whether a drug-free, non-invasive topical patch embedded with Haptic Vibrotactile Trigger Technology (VTT) - the IGNITE Patch (The Super Patch Company) - is associated with changes in resting metabolic rate…
- Conditions
- Resting Metabolic Rate, Energy Metabolism, Haptic Technology, Vibrotactile Stimulation
- Trial name
- OPTIMA (NCT07781384)
- Testing
- IGNITE Patch (Active), Inactive patch
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- SuperPatch Limited LLC
Myopia
Clinical Performance Comparison of Several Different Contact Lenses
The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.
- Trial name
- NCT00912028
- Testing
- senofilcon A, lotrafilcon B, balafilcon A
- Where
- 11 sites in Brazil
- Volunteers
- 71 people
- Sponsor
- Johnson & Johnson Vision Care, Inc.
Multiple Sclerosis
Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis
Study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis.
- Trial name
- CogniPlus (NCT01491100)
- Testing
- Interferon beta-1b (Betaseron, BAY86-5046)
- Where
- 17 sites in Albania, Algeria and 15 more
- Volunteers
- 1,085 people
- Sponsor
- Bayer
Hydrocephalus
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
The SAPPHYRE study is an ambispective (retrospective and prospective) PMCF study with the objective to evaluate the safety and performance of the Polaris® 24 adjustable valve system in the treatment of 126 patients with…
- Trial name
- SAPPHYRE (NCT04746625)
- Where
- 2 sites in France
- Volunteers
- 126 people
- Sponsor
- Sophysa
Bone Regeneration, Dental Implants
Creos Xenoprotect PMCF
The goal of this retrospective PMCF study is to assess safety and performance of creos xenoprotect in all indications functioning as dental barrier membrane.
- Conditions
- Bone Regeneration, Dental Implants, Bone Grafting
- Trial name
- NCT07153185
- Testing
- Dental Barrier Membrane
- Volunteers
- 200 people
- Sponsor
- Nobel Biocare
Type 1 Diabetes, Type 2 Diabetes
Feasibility Study - Integrated Sensor and Infusion Set. Trial III
The purpose of this study is to collect performance data on the Integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and…
- Trial name
- NCT01773668
- Testing
- Integrated sensor and infusion set.
- Where
- Sweden
- Volunteers
- 17 people
- Sponsor
- Medtronic Diabetes R&D Denmark
Thoracic Aortic Diseases
The Single Branch NEXUS™ Clinical Study
A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Subjects will be followed-up for five years.
- Trial name
- NexusSB (NCT03208504)
- Testing
- Nexus™ Aortic Arch Stent graft
- Where
- Germany
- Volunteers
- 1 people
- Sponsor
- Endospan Ltd.
Colorectal Cancer
Paired Analysis of Sensitivity for Colorectal Cancer Using COLVERA : PASCAL
To compare the sensitivity and specificity estimates of Colvera with that of a commercially available CEA test for detection of recurrent disease in subjects with colorectal cancer that have documented recurrence or no evidence…
- Trial name
- PASCAL (NCT03706248)
- Testing
- Blood Draw
- Where
- 6 sites in United States
- Volunteers
- 65 people
- Sponsor
- Clinical Genomics Pathology
Pancreas Cancer, Pancreatic Ductal Adenocarcinoma
Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
Software "Lipidica" is intended to be used for processing data generated by the in-house in vitro diagnostic medical device for lipidomic testing for the purpose of screening Pancreatic cancer (PaC) in the population at high risk…
- Conditions
- Pancreas Cancer, Pancreatic Ductal Adenocarcinoma, Hereditary Diseases, Pancreatitis, Chronic
- Trial name
- NCT06549725
- Testing
- software Lipidica, endoscopic ultrasonography, magnetic resonance
- Where
- 16 sites in Czechia
- Volunteers
- 419 people, healthy volunteers welcome
- Sponsor
- Lipidica, a.s.
Mitral Valve or Aortic Valve Replacement
Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese Patients
To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or 2800TFX) from three hospitals in China. To track the patients'situations during one year after surgery and to collect the relevant clinical…
- Trial name
- NCT02400489
- Where
- 3 sites in China
- Volunteers
- 265 people
- Sponsor
- Edwards Lifesciences
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