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)
Abdominal Aortic Aneurysm
ARBITER-II: Aorfix™ Bifurcated Safety and Performance Trial: Phase II, Angulated Vessels
To assess the safety and performance of Aorfix™ Stent Grafts in the treatment of Abdominal Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel angulation exists at the neck of the aneurysm or in the common iliac…
- Trial name
- ARBITER-II (NCT00442065)
- Testing
- Aorfix™ Stent Grafts (AAA endovascular procedure)
- Where
- 6 sites in Czechia, Germany and 3 more
- Volunteers
- 30 people
- Sponsor
- Lombard Medical
Preterm Delivery
Evaluation of the Clinical Performance of the PremaSure Kit to Assess Premature Delivery Risk in Symptomatic Pregnant Patients
The goal of the study is to determine the clinical performance of the PremaSure kit, more precisely to assess whether the PremaSure kit can be used as a self-test to assess the risk of premature delivery in patients showing…
- Trial name
- NCT07307365
- Where
- Switzerland
- Volunteers
- 800 people
- Sponsor
- Rea Diagnostics SA
C.Surgical Procedure; Cardiac, Haemorrhage.
Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery
The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac and aortic thoracic surgery.
- Trial name
- NCT01879475
- Testing
- 032-11, Floseal (R)
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Medtrade
Craniotomy, Duraplasty
Assessment of the Performance of LYoplant® ONlay for Duraplasty
The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.
- Conditions
- Craniotomy, Duraplasty, Spinal Surgery
- Trial name
- LYON (NCT02678156)
- Testing
- Lyoplant Onlay
- Where
- 3 sites in Germany
- Volunteers
- 61 people
- Sponsor
- Aesculap AG
Adult Cochlear Implant Recipients
Acceptance and Performance of CP1110 Sound Processor With Experienced Adult Cochlear Implant Recipients.
The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound…
- Trial name
- PINNA (NCT05080283)
- Testing
- CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), Nucleus 7 Sound Processor (model: CP1000) system, CP1110 Sound Processor System with ForwardFocus Off (SCAN 2)
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cochlear
Cataract, Lens Opacities
Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.
The clinical investigation is a post-market clinical follow up study whereby patients undergoing routine cataract surgery will have monolateral implantation of a commercially available, CE approved monofocal intraocular lens…
- Trial name
- NCT03297372
- Testing
- IOL implantation
- Where
- 2 sites in Italy
- Volunteers
- 121 people
- Sponsor
- Beaver-Visitec International, Inc.
Spine Surgery
An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)
The purpose of this research study is to: test the usability and performance of the medical device Surgify Halo ™ in spine surgery test the level of "chattering " during the use of the device test the cutting performance of…
- Trial name
- NCT06827795
- Testing
- A burr used in spine surgery
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Surgify Medical Oy
Fertility Disorders
Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation
This is an observational, prospective, single-arm, multi-center, clinical study to evaluate the performance of CHLOE, an Artificial Intelligence (AI)-based software application, as adjunct information to support identifying…
- Trial name
- CHLOE (NCT05455281)
- Testing
- CHLOE
- Where
- 3 sites in United States, Israel
- Volunteers
- 55 people
- Sponsor
- Fairtility
Multiple Organ Failure
Feasibility Study of MicroKine Dx System in Critically-ill Pediatric Patients.
This study will enroll approximately 25 pediatric patients to assess the performance and real-world feasibility of multi-biomarker based prognostic and predictive algorithms to aid in the clinical management of pediatric…
- Trial name
- NCT04295278
- Testing
- MicroKine Dx system
- Volunteers
- 25 people
- Sponsor
- PreDxion Bio, Inc.
Heart Failure
The WiSE®-UP Study (The WiSE System Utilization & Performance Study)
Observe to understand product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System
- Trial name
- NCT07098858
- Testing
- The Wise System
- Where
- 12 sites in United States
- Volunteers
- 320 people
- Sponsor
- EBR Systems, Inc.
Motion Sickness
A Comparative Bioavailability and Adhesion Performance Study, Comparing a New Scopolamine Transdermal Delivery System Formulation to the Currently Established Reference Transdermal Delivery System in Healthy Adult Participants.
In this comparative bioavailability and in vivo skin adhesion study, the impact of minor changes in qualitative composition of polyiso-Butylenes (PIB) from a different supplier and change of the manufacturing line of the micro…
- Trial name
- NCT02839135
- Testing
- Reformulated scopolamine patch, Marketed scopolamine patch
- Where
- Canada
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bladder Cancer
A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
The objective of this prospective, multi-centre study is to evaluate the performance of ADXBLADDER, a urine MCM5 ELISA test, as an aid in the detection of bladder cancer recurrence.
- Trial name
- NCT05508568
- Testing
- ADXBLADDER
- Where
- 13 sites in United States
- Volunteers
- 650 people
- Sponsor
- Arquer Diagnostics Ltd
Leg Ulcer, Diabetic Foot Ulcer
Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e.
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer, Surgical Wound
- Trial name
- GELFI (NCT05148390)
- Testing
- Cutimed® Gelling Fiber
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- BSN Medical GmbH
Ankle Injuries and Disorders
Observational Study to Evaluate Safety and Performance of the Total Ankle Prosthesis, EasyMove®
This study is a post-market clinical follow-up conducted in order to collect long-term data on safety and performance of the EasyMove prosthesis, which is intended to be implanted in case of total ankle replacement, when used in…
- Trial name
- NCT04944576
- Testing
- Total Ankle Prosthesis, EasyMove®
- Where
- 6 sites in France, Switzerland
- Volunteers
- 82 people
- Sponsor
- FH ORTHO
IBS - Irritable Bowel Syndrome
Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS)
A three month follow-up study to evaluate the effectiveness of a tailored anti-inflammatory eating plan guided by a registered dietitian to treat irritable bowel syndrome.
- Trial name
- NCT05178017
- Testing
- Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Oxford Biomedical Technologies, Inc.
Alzheimer's Disease
[18F]MK-3328 as a Possible Novel Positron Emission Tomography (PET) Tracer for the Detection of Brain Amyloid Plaques (MK-3328-002)
The purpose of this study is to evaluate radiolabeled [18F]MK-3328 as a PET tracer for estimating the regional distribution and extent of amyloid plaques in participants suffering from amnestic mild cognitive impairment (aMCI)…
- Trial name
- NCT01385033
- Testing
- [18F]MK-3328
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Diabetes
Evaluation of an Ascensia Diabetes Care ONYX PLUS Investigational Blood Glucose Monitoring System
The purpose of this study was to determine if untrained subjects with diabetes can operate the Investigational ONYX PLUS Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
- Trial name
- NCT02371876
- Testing
- ONYX PLUS Investigational Blood Glucose Monitoring System
- Where
- 2 sites in United States
- Volunteers
- 134 people
- Sponsor
- Ascensia Diabetes Care
Cochlear Hearing Loss
Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation
This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound…
- Trial name
- NCT06301568
- Where
- Germany
- Volunteers
- 55 people
- Sponsor
- Advanced Bionics AG
Cardiovascular Risk
Precision Study of CLAiR AI Software
This multi-site precision study evaluated the performance and reproducibility of the CLAiR artificial intelligence (AI) software in identifying elevated risk of atherosclerotic cardiovascular disease (ASCVD) from retinal fundus…
- Trial name
- NCT07747233
- Testing
- CLAiR Artificial Intelligence Software
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Toku Eyes Ltd
Endometrial Cancer
Evaluation of MCM5 in Postmenopausal Bleeding Patients
The objective of this multi-centre, prospective study, is to evaluate the performance of a urine MCM5 ELISA test (ADXGYNAE) in the detection of endometrial cancer in patients with postmenopausal bleeding.
- Trial name
- NCT05287048
- Testing
- MCM5 ELISA
- Where
- United Kingdom
- Volunteers
- 2,000 people
- Sponsor
- Arquer Diagnostics Ltd
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