Clinical trials: Safety and Usability
Monitor Acne Lessions Count Reduction as Result of Usinfg the Device
Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for Acne Treatment
This is a clinical research study to determine the ability of the Clear device to treat mild to moderate inflammatory acne, and to determine if the average person is able to use the device properly according to the labeling as…
- Trial name
- NCT01678482
- Testing
- light based device for treatment of acne
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Home Skinovations Ltd.
Non-muscle-invasive Bladder Cancer
T-Control® Safety for Cytostatics Management
The goal of this pilot clinical trial is to know if this study is feasable in terms of design, recruitment and interventions, as well as gather preliminary data to determine if the T-Control® catheter is safer than the…
- Trial name
- NCT06678633
- Testing
- T-Control® (experimental), Folysil® (control)
- Volunteers
- 16 people
- Sponsor
- Rethink Medical SL
Gastrointestinal Cancer
Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran® 2 Usability Trial in EMR and ESD
The aim of this single-center study is to evaluate the feasibility of the technique, usability and safety of the device ENDONEB.
- Trial name
- NCT06588881
- Testing
- nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection
- Where
- Italy
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GEM SRL
Heart Failure
V-Lap System For Wirelessly Measuring And Monitoring Left Atrial Pressure (LAP) In Patients With Advance CHF
The objective of this study is to evaluate the safety and performance of the V-LAP System in subjects with New York Heart Association (NYHA) functional class II and III HF, irrespective of left ventricular ejection fraction.
- Trial name
- NCT05712824
- Testing
- V-LAP™ SYSTEM
- Where
- 3 sites in Georgia
- Volunteers
- 10 people
- Sponsor
- Vectorious Medical Technologies Ltd.
End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis
Human Factors Validation Testing for the Peripal System; a Manual Connection Assist Device for Peritoneal Dialysis Devices
It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but…
- Conditions
- End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis, Renal Failure, Peritoneal Dialysis
- Trial name
- NCT04292210
- Testing
- Perisafe
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Peripal AG
Guillain Barré Syndrome
Exoskeleton Gait Training in Guillain-Barré Syndrome: Safety, Feasibility, Usability, and Longitudinal Outcomes
The main objective of the study is to determine if the Atalante X exoskeleton by Wandercraft is a safe, reliable, and usable device for people with Guillain-Barré Syndrome (GBS) who are unable to walk.
- Trial name
- Atalante GBS (NCT07556809)
- Testing
- Exoskeleton Wandercraft Atalante X, usability and gait rehabilitation
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Institut Guttmann
Diabetes Mellitus, Type 1
MiniMed™ 670G System China Study for Type I Diabetic
The purpose of this study is to obtain clinical data in Chinese patients to support product registration of the MiniMed™ 670G system with the National Medical Product Administration (NMPA) in China.
- Trial name
- NCT04663295
- Testing
- MiniMed™ 670G system
- Where
- 4 sites in China
- Volunteers
- 74 people
- Sponsor
- Medtronic MiniMed, Inc.
Cystic Fibrosis in Children
Percussion Palm Cup: Safety and Usability in Infants and Children With Cystic Fibrosis
Cystic Fibrosis is the most prevalent fatal genetic disease affecting Canadian children and it primarily characterized by a thickening of pulmonary secretions and impaired mucociliary clearance.
- Trial name
- PPC (NCT04835376)
- Testing
- Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic Fibrosis
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- West Park Healthcare Centre
Neovascular Age-related Macular Degeneration, Macular Oedema Secondary to RVO
A Trial to Evaluate the Safety and Usability of the SB15 PFS in Trial Participants With AMD, Macular Oedema Secondary to RVO, or Diabetic Macular Oedema
This is an open label, multicenter, Phase II trial to evaluate the safety and usability of the pre-filled syringe (PFS) of SB15 (Aflibercept biosimilar).
- Conditions
- Neovascular Age-related Macular Degeneration, Macular Oedema Secondary to RVO, Diabetic Macular Oedema
- Trial name
- NCT07844343
- Testing
- SB15 PFS
- Where
- 3 sites in South Korea
- Volunteers
- 33 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Atrial Flutter
Evaluation of the Safety, Feasibility and Usability of the EPD D700 System in Atrial Flutter Ablation Procedures
Demonstrate the safety, feasibility and usability of the EPD D700 system, for the first time in humans, in subjects undergoing ablation for the treatment of atrial flutter.
- Trial name
- NCT02768051
- Testing
- AF Ablation
- Sponsor
- EPD Solutions, A Philips Company
Neurological Disorders, Health Adult Subjects
Device for Driving Simulation for the Rehabilitation of Balance and Proprioception
The DriveSim clinical trial investigates a dynamic driving simulator designed to train and assess functional motor and cognitive skills in individuals with neurological disorders.
- Trial name
- DRIVESIM (NCT07539272)
- Testing
- DriveSim Rehab, Conventional Rehabilitation
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Pavia
Virtual Reality
Usability, Acceptability, and Safety of Virtual Reality-based Cognitive Intervention
This study aims to determine feasibility, acceptability, and usability, and to assess the safety of using a virtual reality-based software called ''ReCognitionVR'' in healthy volunteers.
- Trial name
- NCT05583903
- Testing
- Virtual Reality Software
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- The Methodist Hospital Research Institute
Neuromuscular Disorders, Neurodevelopmental Disorders
Safety, Usability, and Effectiveness of a Gait Exoskeleton for Children and Adolescents With Neurodevelopmental Disorders.
Neurodevelopmental disorders often result in abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as the inability to stand and walk.
- Trial name
- NCT07159360
- Testing
- CLINICAL EXPLORER
- Where
- 2 sites in Mexico, Spain
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- MarsiBionics
Social Phobia
Pilot Study: VR Mind and VR Mind+ Intervention
The aim of the pilot study is feasibility, usability and safety assessment of VR Mind intervention. In particular the subject of assessment will be: the length of the laboratory session utilizing virtual reality exposure…
- Trial name
- NCT03647605
- Testing
- VR Mind
- Where
- Poland
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Tomorrow Sp. z o.o.
Intracranial Aneurysm, Brain Arterial Disease
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.
- Conditions
- Intracranial Aneurysm, Brain Arterial Disease, Acute Ischemic Stroke, Peripheral Vascular Diseases
- Trial name
- EVIDENCE (NCT04927156)
- Testing
- BALT medical devices
- Where
- 12 sites in France, Germany and 1 more
- Volunteers
- 10,000 people
- Sponsor
- Balt Extrusion
Cystic Fibrosis, Adherence, Medication
Evaluation of the ReX-C System, in Patients Receiving CFTR Modulators for the Treatment of Cystic Fibrosis (CF).
Cystic fibrosis (CF) is a progressive multisystem disorder characterized by abnormalities in the transport of chloride ions in human airway epithelial cells, leading to frequent lung infections, decreased pulmonary function…
- Trial name
- NCT04215796
- Testing
- ReX-C system
- Where
- 2 sites in Israel
- Volunteers
- 10 people
- Sponsor
- Dosentrx Ltd.
Detection Accuracy, Patient Compliance
Reliability, Safety and Usability of the Transplantation Sensor System Combined With Myfortic® in Adult Kidney Transplant Patients
The main purpose of this exploratory trial is to evaluate the reliability, safety and usability of the Transplantation Sensor System when the Ingestible Event Marker (IEM) is given in combination with ECMPS 360 mg tablets in…
- Trial name
- NCT01320358
- Testing
- ECMPS-IEM
- Where
- 5 sites in Switzerland
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
IUD Insertion
Usability, Safety and Efficacy of AspivixTM (Comparative Study)
Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD).
- Trial name
- NCT04441281
- Testing
- Traction of the cervix for IUD insertion
- Where
- 2 sites in Switzerland
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Aspivix SA
Spinal Cord Injuries, Gait Disorders, Neurologic
Safety and Feasibility of TWIICE Rise - Phase 2
The aim of this study is to assess the safety and the feasibility of two versions of TWIICE Rise for exoskeleton-assisted ambulation in patients with a spinal cord injury.
- Trial name
- NCT07461259
- Testing
- TWIICE Rise
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- TWIICE
Plaque-type Psoriasis
Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)
The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
- Trial name
- JUNCTURE (NCT01636687)
- Testing
- Secukinumab 150mg, Secukinumab 300mg
- Where
- 39 sites in United States, Canada and 3 more
- Volunteers
- 182 people
- Sponsor
- Novartis Pharmaceuticals