Clinical trials: Clinical Performance
Meningitis/Encephalitis
QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study 001
Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.
- Trial name
- NCT05092438
- Where
- United Kingdom
- Volunteers
- 595 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Cataract, Lens Opacities
Clinical Study to Investigate Outcomes of Trifocal Toric IOL POD FT in Asian Eyes
Prospective, controlled, single-surgeon, single-center clinical study to compare visual acuity outcomes to data obtained in a similar study by the same principal investigator on the trifocal IOL POD F (study no.
- Conditions
- Cataract, Lens Opacities, Presbyopia
- Trial name
- NCT03844828
- Testing
- IOL implantation experimental
- Where
- Philippines
- Volunteers
- 100 people
- Sponsor
- Beaver-Visitec International, Inc.
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW III Asia Registry Orsiro Stent System
Cliflical evaluation of th' Orsiro LESS 10 diabetic subjects requiring coronary revasculariza t ion with Drug Eluting Stefl ts (DES) .880 subjects will be enrolled in this registry.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Diabetes Mellitus Type 1 or 2
- Trial name
- NCT01941290
- Where
- 19 sites in China, India and 3 more
- Volunteers
- 387 people
- Sponsor
- BIOTRONIK Asia Pacific Pte Ltd
Lyme Borreliosis
Performance Evaluation of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis
The clinical data from the clinical trial will be used to assess the performance, sensitivity and specificity of the experimental DualDur In Vitro Diagnostic System.
- Trial name
- NCT03873974
- Testing
- DualDur dark-field microscopic test, DualDur dark-field automatic microscopic test, Western blot IgM and IgG
- Where
- 8 sites in Austria, Czechia and 4 more
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Lyme Diagnostics Ltd.
Tachyarrhythmias, Heart Failure
Safety and Clinical Performance of the Protecta ICD and CRT-D
The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic…
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00982397
- Testing
- Protecta VR-ICD, Protecta DR-ICD or CRT-D
- Where
- 122 sites in United States, Austria and 19 more
- Volunteers
- 2,770 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
ECG, Electrocardiography
Validation of Perin Health Patch ECG Monitoring Device Performance and Placement Accuracy
The goal of this clinical trial is to test how accurately and reliably a new chest-worn device called the Perin Health Patch measures heart rhythms (ECG) in adults aged 22 and older.
- Conditions
- ECG, Electrocardiography, Monitoring, Physiologic
- Trial name
- NCT07147920
- Testing
- Chest-Worn ECG Monitoring Device
- Where
- United States
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- Perin Health Devices
Wound Heal, Wound; Foot
Management of Acute and Chronic Wounds With Hyaluronic Acid
The purpose of this study is to evaluate the performance and safety of Connettivina Bio, when used in the management of wounds. Moreover, the study will evaluate the correlation of the 'dressing system' (formed by the…
- Trial name
- NCT06108999
- Testing
- Connettivina BIO cream and gauze
- Where
- 3 sites in Italy
- Volunteers
- 170 people
- Sponsor
- Fidia Farmaceutici s.p.a.
Atrial Fibrillation
Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)
The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical study.
- Trial name
- NCT02944968
- Testing
- THERMOCOOL SMARTTOUCH® SF-5D catheter
- Volunteers
- 51 people
- Sponsor
- Biosense Webster, Inc.
Cystoscope, Lower Urinary Tract Symptoms
Evaluation of Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy
In this study, the new aScope 4 Cysto is used to see if this new single use, flexible cystoscope performs as well as other routinely used flexible cystoscopes.
- Conditions
- Cystoscope, Lower Urinary Tract Symptoms, Bladder Disease
- Trial name
- NCT04192474
- Testing
- Flexible cystoscopy
- Where
- 2 sites in Denmark, Netherlands
- Volunteers
- 83 people
- Sponsor
- Ambu A/S
Sacrocolpopexy
Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted sacrocolpopexy or sacrocervicopexy.
- Trial name
- SPARO (NCT07031050)
- Testing
- sacrocolpopexy or sacrocervicopexy
- Where
- 6 sites in Germany, Switzerland
- Volunteers
- 35 people
- Sponsor
- Distalmotion SA
Myopia
The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems
This will be a controlled and randomized, single-masked, crossover study in which 48 subjects will use the Biofinity Contact Lens (comfilcon A) with each of the two lens care products ('solutions'), (Synergi and Biotrue…
- Trial name
- NCT02510820
- Testing
- comfilcon A, Synergi, Biotrue
- Where
- United Kingdom
- Volunteers
- 51 people
- Sponsor
- CooperVision, Inc.
Mechanically Ventilated Patients
Pilot Clinical Investigation to Evaluate a Prototype of Sensor Measuring Ventilator-derived Parameters
Recently, the threat of viral pandemics (Covid-19, severe acute respiratory syndrome, avian flu H5N1, and H1N1), which might result in thousands of patients requiring mechanical ventilation, has accelerated the need for…
- Trial name
- NCT06054503
- Testing
- prototype of sensor
- Where
- France
- Volunteers
- 59 people
- Sponsor
- Archeon
Knee Pain Chronic, Osteoarthritis
Persona Ti-Nidium Post-Market Clinical Follow-up
The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
- Conditions
- Knee Pain Chronic, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- Trial name
- TKA (NCT04817969)
- Testing
- Zimmer Biomet Persona Ti-Nidium Total Knee System
- Where
- 7 sites in United States
- Volunteers
- 240 people
- Sponsor
- Zimmer Biomet
Diabetes, Endocrine, Nutritional and Metabolic Diseases (E00-E89)
COMPLEMENT Study- A First in Human Study of Metabolic Neuromodulation Therapy
The purpose of this research study is to collect information about a new treatment for Type 2 Diabetes Mellitus (T2DM), using a medical device called the Metabolic Neuromodulation System which is intended to help regulate blood…
- Trial name
- NCT02278068
- Testing
- Metabolic Neuromodulation System (MNS)
- Where
- 6 sites in New Zealand
- Volunteers
- 46 people
- Sponsor
- Metavention
Coronary Disease, Heart Diseases
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions
The objective of this study is to assess the safety and efficacy of the Freesolve resorbable magnesium scaffold (RMS) in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to the Xience…
- Conditions
- Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- BIOMAG-III (NCT07258290)
- Testing
- Freesolve RMS, Xience DES
- Where
- 3 sites in United States, Latvia
- Volunteers
- 1,859 people
- Sponsor
- Teleflex
Intracranial Aneurysm
Post-Market Clinical Follow-Up Study to Confirm Clinical Performance and Safety of the Codman Enterprise® 2 Vascular Reconstruction Device in the Endovascular Treatment of Intracranial Aneurysms
The objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of the Codman Enterprise® 2 when used in conjunction with endovascular coil embolization of ruptured or non-ruptured…
- Trial name
- SUNRISE-2 (NCT02415010)
- Testing
- Enterprise 2 Vascular Reconstruction Device
- Where
- 10 sites in Germany, Spain and 2 more
- Volunteers
- 26 people
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
Abdominal Aortic Aneurysm
Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Abdominal Aortic Aneurysm Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD.
- Trial name
- NCT03687489
- Testing
- Abdominal Aortic Aneurysm Stent Graft System
- Where
- 22 sites in China
- Volunteers
- 156 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Rheumatoid Arthritis With Adequate Bone Quality, Inflammatory Arthritis
PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty
This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System…
- Conditions
- Rheumatoid Arthritis With Adequate Bone Quality, Inflammatory Arthritis, Osteoarthritis, Hip, Avascular Necrosis
- Trial name
- NCT03372278
- Where
- 8 sites in Australia, Belgium and 6 more
- Volunteers
- 250 people
- Sponsor
- Zimmer Biomet
Atrial Fibrillation, Tachycardia
Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm
The SWAF study will compare the performance of a smartwatch combined with Cardiologs Platform algorithm in the detection of Atrial Fibrillation and other arrhythmias with that measured on a manually read 12-lead ECG in subjects…
- Conditions
- Atrial Fibrillation, Tachycardia, Bradycardia, Premature Supraventricular Beat
- Trial name
- NCT05167058
- Testing
- Cardiologs Platform
- Where
- 3 sites in United States
- Volunteers
- 220 people
- Sponsor
- Cardiologs Technologies
Venous Leg Ulcer, Pressure Ulcer
Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in…
- Conditions
- Venous Leg Ulcer, Pressure Ulcer, Diabetic Foot Ulcer, Chronic Ulcer
- Trial name
- ASOLO-CW (NCT04753294)
- Testing
- Avance Solo NPWT System, Avance Solo Adapt NPWT System
- Where
- 13 sites in Belgium, Denmark and 5 more
- Volunteers
- 136 people
- Sponsor
- Molnlycke Health Care AB