Clinical trials: Performance
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
D012039, D001775
Measuring Cardiovascular Performance and Blood Flow Using Common But Never Compared Methods.
Measuring Cardiovascular Performance Using Common Methods in subjects.
- Trial name
- NCT04553484
- Testing
- No intervention
- Where
- 4 sites in United States
- Volunteers
- 657 people
- Sponsor
- Semler Scientific
Hypoxia
Accuracy of Pulse Oximeters in Profound Hypoxia
The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100%. Two devices were placed on each subject with one on the finger and the other on the fingertip.
- Trial name
- NCT05920278
- Testing
- Pulse oximeter
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Movano Health
Attention Deficit Hyperactivity Disorder
Comparison of Atomoxetine Versus Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6 through 12 years with…
- Trial name
- NCT00546910
- Testing
- Atomoxetine
- Where
- 16 sites in Germany
- Volunteers
- 125 people
- Sponsor
- Eli Lilly and Company
Performance and Tolerance of Colonoscopy
Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study
Colonoscopy is the gold-standard for colorectal cancer screening in the US. However, complete colonoscopy can be a challenging technical procedure, even for expert gastroenterologists due to variations in patient anatomy…
- Trial name
- C3PO (NCT02025504)
- Testing
- ColoWrap
- Where
- 3 sites in United States
- Volunteers
- 350 people
- Sponsor
- ColoWrap, LLC
Wrist Fracture, Proximal Humerus Fracture
PMCF Study on the Safety, Performance and Clinical Benefits Data of the XtraFix® Small External Fixation System
The study is a monocentric, retrospective, 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 XtraFix® Small External…
- Trial name
- NCT05943574
- Where
- Italy
- Volunteers
- 91 people
- Sponsor
- Zimmer Biomet
Wound and Injuries, Surgical Wound Dehiscence
The Clinical Efficacy of RENASYS TOUCH NPWT System in the Management of Acute, Sub-acute and Chronic Wounds
The study is looking at the clinical efficacy, functionality and device performance of a new Negative Pressure Wound Therapy (NPWT) system in the management of a variety of wound types, in a real-life clinical setting.
- Trial name
- NPWT (NCT02565043)
- Testing
- RENASYS TOUCH Negative Pressure Wound Therapy System
- Where
- 2 sites in South Africa
- Volunteers
- 80 people
- Sponsor
- Smith & Nephew, Inc.
Cardiovascular Diseases
A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)
The objective of this post marketing observational registry is to evaluate clinical outcomes (safety and performance) in an all-comers population with coronary artery disease (CAD) treated with the Polymer Free Sirolimus Eluting…
- Trial name
- NCT06412250
- Where
- 32 sites in India, Italy and 2 more
- Volunteers
- 2,000 people
- Sponsor
- Translumina Therapeutics Pvt Ltd.
Healthy, Cognitive Performance
Evaluate the Effects of Citicoline on Cognitive Performance in Healthy Adults
Cognizin is a patented form of citicoline, a natural compound of the brain tissue. It is believed that Cognizin can support brain function by boosting brain energy and protecting brain cells.
- Trial name
- NCT06906848
- Testing
- Cognizin®
- Where
- Canada
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Kirin Holdings Company, Limited
Pregnancy, Down Syndrome
Comparison of Aneuploidy Risk Evaluations
This is a prospective, multi-center observational study designed to compare the test results of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening for fetal chromosome abnormalities in…
- Conditions
- Pregnancy, Down Syndrome, Edwards Syndrome, Patau Syndrome
- Trial name
- CARE (NCT01663350)
- Where
- 26 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- Verinata Health, Inc.
Osteoarthritis of the Shoulder, Avascular Necrosis
Database Retrieval for the Comprehensive Shoulder
This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products.
- Conditions
- Osteoarthritis of the Shoulder, Avascular Necrosis, Rheumatoid Arthritis, Prior Failed Revision
- Trial name
- NCT03409718
- Testing
- Biomet Comprehensive Shoulder System
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Zimmer Biomet
Pelvic Organ Prolapse (POP), Synthetic Mesh
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
The purpose of this clinical investigation is to collect clinical data about the ProGYNious Mesh based on a prospective clinical investigation.
- Conditions
- Pelvic Organ Prolapse (POP), Synthetic Mesh, Laparoscopic Surgery, Gynecologic Laparoscopic Surgery
- Trial name
- ProGYNious (NCT07497321)
- Testing
- Surgical mesh for pelvic organ prolapse repair (ProGYNious)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 100 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Bloodstream Infection, Sepsis
Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care…
- Conditions
- Bloodstream Infection, Sepsis, Septic Shock
- Trial name
- IID-BSIqPCR (NCT06531031)
- Testing
- InfectID-BSI (Bloodstream Infection) qPCR Assay
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 1,500 people
- Sponsor
- Microbio Co Ltd
Diabetes
Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System
The purpose of this study is to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) without training and obtain valid glucose results.
- Trial name
- NCT02041286
- Testing
- Karajishi Contour Investigational BG Monitoring System
- Where
- 2 sites in United States
- Volunteers
- 136 people
- Sponsor
- Ascensia Diabetes Care
Enterostomy, Stoma Ileostomy
Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients
The study is designed as a non-interventional, prospective, international, multi-center, post market follow-up investigation. The product under investigation will be used in routine clinical practice and according to Instructions…
- Conditions
- Enterostomy, Stoma Ileostomy, Stoma Colostomy
- Trial name
- NCT05373888
- Testing
- Flexima®/Softima® stoma bags
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- BBraun Medical SAS
Bacterial Vaginosis
Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis
This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with confirmed bacterial vaginosis (BV) according to fulfillment of at least 3…
- Trial name
- NCT03762083
- Testing
- pHyph generation I
- Where
- 2 sites in Sweden
- Volunteers
- 24 people
- Sponsor
- Gedea Biotech AB
Blood Glucose Measurement
OneTouch Select® [Brand Name]Plus Blood Glucose Monitoring System(BGMS) Registration Study
This study is to support the regulatory application of OneTouch Select® Plus test strips in China. The blood glucose test strip is regulated as an In Vitro Diagnostic (IVD) product and China Food and Drug Administration (CFDA)…
- Trial name
- NCT02810522
- Testing
- OneTouch Select® Plus Glucose Test Strips
- Sponsor
- Johnson & Johnson Medical, China
Migraine
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
This is a prospective, randomized, open-label, delayed-start clinical investigation evaluating the safety and efficacy of the Walther System, a Class IIa investigational medical device delivering intra-nasal mechanical…
- Trial name
- A-MI-01 (NCT07279623)
- Testing
- INMEST-treatment
- Where
- Sweden
- Volunteers
- 110 people
- Sponsor
- Abilion Medical Systems AB
Thrombolysis
CaveoVasc Thrombolysis Protection System, Access Protection Study
The CaveoVasc Thrombolysis Protection System is intended to aid sheath access and reduce bleeding complications during catheter directed thrombolysis (CDT) in the treatment of limb ischemia.
- Trial name
- NCT03166059
- Testing
- CaveoVasc® Thrombolysis Protection System
- Volunteers
- 20 people
- Sponsor
- CaveoMed GmbH
Heart Failure, Heart Failure - NYHA II - IV
Evaluation of Liver Stiffness Performance, by FibroScan®, to Detect Elevated Central Venous Pressure (CVP)
This is a pivotal, global, prospective, cross-sectional, multicentric clinical investigation designed to explore a non-invasive, reliable alternative to invasive, catheter-based hemodynamic assessments, which are associated with…
- Trial name
- NCT07222813
- Testing
- FibroScan, Right-sided Heart Catheterization, Transthoracic echocardiography
- Where
- 7 sites in United States, France and 2 more
- Volunteers
- 149 people
- Sponsor
- Echosens
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