Clinical trials: Performance and Safety
Acute Upper Gastrointestinal Hemorrhage, Acute Upper Gastrointestinal Bleeding
Clinical Investigation of Safety and Performance of a Medical Device (ClearPlasma) for the Treatment of Patients With Acute Upper Gastrointestinal Hemorrhage.
Pre-market, multi-center, international, double-blind, randomized, controlled, prospective, first-in-human clinical investigation of a Class IIb Investigational Medical Device, in which Patients presenting with acute upper…
- Trial name
- NCT04174989
- Testing
- Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device), Regular fresh-frozen plasma (not treated)
- Where
- 8 sites in Czechia, Israel and 1 more
- Volunteers
- 53 people
- Sponsor
- PlasFree Ltd.
Restless Legs Syndrome
Simulated Driving Study in Restless Legs Syndrome
This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS).
- Trial name
- XP083 (NCT01332318)
- Testing
- XP13512, Diphenhydramine
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- XenoPort, Inc.
Acne Scars
Clinical Evaluation of Fractional Radiofrequency for the Treatment Acne Scarring
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of acne scarring.
- Trial name
- NCT03821324
- Testing
- Venus Viva
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Type 2 Diabetes Mellitus
A Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2 diabetes mellitus (T2DM).
- Trial name
- NCT02419859
- Testing
- PaQ® Insulin Delivery Device, Insulin, Asp(B28)-
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- CeQur Corporation
Sacroiliac; Fusion, Sacroiliac
Prospective SPINE Registry
This study is a prospective, multi-center, open label registry designed to collect real-world data on performance and safety data on RTI's spine products.
- Conditions
- Sacroiliac; Fusion, Sacroiliac, Joint Diseases, Musculoskeletal Diseases
- Trial name
- SPINE (NCT04176562)
- Testing
- RTI Spine products
- Where
- 12 sites in United States, Germany and 1 more
- Volunteers
- 5,000 people
- Sponsor
- Xtant Medical
Atrial Fibrillation
Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
- Trial name
- PULSE-EU (NCT05164107)
- Testing
- Globe Mapping and Pulsed Field Ablation System (Globe PF System)
- Where
- Czechia
- Volunteers
- 175 people
- Sponsor
- Kardium Inc.
Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract
Clinical Evaluation of the Safety and Performance of Microwave Coagulation Using the HS1 Instrument
Clinical evaluation of the safety and performance of microwave coagulation using the HS1 Instrument for actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract
- Trial name
- NCT04406116
- Testing
- Microwave coagulation using HS1 Instrument
- Where
- United Kingdom
- Volunteers
- 35 people
- Sponsor
- Creo Medical Limited
Dyslexia
Evaluation of the Performance and Safety of a Medical Device Developed to Improve the Reading of Dyslexic Patients
The aim of this study is to evaluate the efficacy and safety of a new medical device on the improvement of reading skills of dyslexic patients.
- Trial name
- DysLight (NCT04157829)
- Testing
- Scintilling lamp, Classic lamp
- Where
- 4 sites in France
- Volunteers
- 33 people
- Sponsor
- SATT Ouest Valorisation
Dry Eye
A Study to Evaluate the Performance and Safety of CBL-101 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
The primary objectives of this investigation are to show that the performance of CBL-101 Eye Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe keratoconjunctivitis sicca after 28 days…
- Trial name
- NCT02975102
- Testing
- CBL-101 Eye Drops, Vismed® Multi Eye Drops
- Where
- 2 sites in Belgium, France
- Volunteers
- 87 people
- Sponsor
- Laboratoire Chauvin
Cataract
Cataract Surgery: Femto LDV Z8 Versus Conventional
The aim of the study is to demonstrate the performance and safety of the Femtosecond laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV Z8 compared to conventional technique in cataract…
- Trial name
- COMFORT (NCT02351271)
- Testing
- Femto LDV Z8, Manual capsulorhexis&lens fragmentation
- Volunteers
- 130 people
- Sponsor
- Ziemer Ophthalmic Systems AG
Hearing Loss
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided…
- Trial name
- NCT04041700
- Testing
- Osia 2 system
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 29 people
- Sponsor
- Cochlear
Cerebral Palsy
Safety and Performance of Agilik in CP
The purpose of this post market study is to demonstrate the safety and performance of a powered extension assist (EA) knee ankle foot orthosis (KAFO), or EA-KAFO, in individuals with knee extension deficiency due to cerebral…
- Trial name
- Agilik (NCT05746871)
- Testing
- Agilik, standard care
- Where
- Italy
- Volunteers
- 9 people
- Sponsor
- IRCCS Eugenio Medea
Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia
Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
This prospective observational study will evaluate the safety and performance of the MiniLung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure.
- Conditions
- Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia, Acute Respiratory Failure, Acute Lung Injury
- Trial name
- PETIT (NCT06750536)
- Testing
- MiniLung petite kit combined with the Xenios console
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Xenios AG
Dural Defect, Cerebrospinal Fluid Leak
Immiseal™ Dural Sealant Post-Market Registry Study
This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct…
- Conditions
- Dural Defect, Cerebrospinal Fluid Leak, Neurosurgical Procedures
- Trial name
- NCT07651826
- Where
- Latvia
- Volunteers
- 85 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Peripheral Arterial Disease
Safety and Performance Study of the Shockwave Lithoplasty System
To study the safety and performance of the Shockwave Medical Lithoplasty System in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of…
- Trial name
- DISRUPT-PAD (NCT02071108)
- Testing
- Shockwave Lithoplasty System
- Where
- 3 sites in Austria, Germany and 1 more
- Volunteers
- 35 people
- Sponsor
- Shockwave Medical, Inc.
Localized T1-T2 Prostate Cancer
SpaceOAR System RWS in China
This study aims to evaluate the safety and performance of SpaceOAR System when it is used to create space between the rectum and prostate in men undergoing radiotherapy for localized T1-T2 prostate cancer in China via collecting…
- Trial name
- NCT05407714
- Testing
- SpaceOAR Treatment
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Rheumatoid Arthritis
The SetPoint System Safety & Performance Post-Approval Study
Prospective, multicenter, post-market, registry study designed to systematically collect real-world data (RWD) from participants implanted with the SetPoint System [implanted, vagus-mediated, neuroimmune modulator] for the…
- Trial name
- ACTIVATE (NCT07489326)
- Testing
- SetPoint System
- Volunteers
- 150 people
- Sponsor
- SetPoint Medical Corporation
Temporomandibular Joint Disorders
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
This is a long-term (10 years), retrospective-prospective, observational, single-arm, monocenter study of patients to be treated with the Materialise TMJ Total Arthroplasty System for TMJ replacement.
- Trial name
- NCT06951178
- Testing
- TMJ Total Arthroplasty System (TMJ System)
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- Materialise
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.
Atrial Fibrillation
Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation
This study will evaluate the safety and acute performance of the Globe® Mapping and Ablation System with the GPS™ Module intended to conduct electroanatomic mapping and ablation treatment of subjects with atrial fibrillation (AF).
- Trial name
- GPS-CA (NCT04486924)
- Testing
- Globe Mapping and Ablation System
- Where
- 2 sites in Canada
- Volunteers
- 18 people
- Sponsor
- Kardium Inc.