Clinical trials: Safety and Usability
Children Under 18 Years Old With Kidney Disease
Study of FFI-1010 in Pediatric Kidney Disease
The purpose of this study is revealing that the ratio of creatinine clearance (Ccr) to inulin clearance (Cin) measuring at the same time is more than 1.2.
- Trial name
- NCT03345316
- Testing
- FFI-1010
- Where
- Japan
- Volunteers
- 60 people
- Sponsor
- Fuji Yakuhin Co., Ltd.
Incontinence, Urge
T-DOC® 5 Fr Pediatric Clinical Investigation
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
- Trial name
- NCT03429270
- Testing
- TDOC 5Fr
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
Spinal Cord Injury (SCI)
Safety and Usability of the ATLAS 2030 Exoskeleton in Pediatric Patients With Spinal Cord Injury
The goal of this clinical trial is to analyze the usability and safety of the robotic gait ATLAS 2030 in a cohort of pediatric patients with Spinal Cord Injury, with the aim of extending its indication for use to pediatric spinal…
- Trial name
- NCT06772077
- Testing
- Rehabilitation treatment with ATLAS2030
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- MarsiBionics
Multiple Sclerosis, Ataxia
"Evaluation of Usability and Safety of the Self-balancing Walking System Atalante in Patients With Multiple Sclerosis"
Multiple sclerosis (MS) is the most prevalent chronic inflammatory disease of the central nervous system (CNS), affecting more than 2 million people worldwide,1 it is a degenerative disease that selectively affects the central…
- Conditions
- Multiple Sclerosis, Ataxia, Paraplegia
- Trial name
- EXO (NCT05563402)
- Testing
- Atalante
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- Multiple Sclerosis Center of Catalonia
Intubated Patients
Pilot Study of the Sage Guard for Oral Cavity Protection
The study will evaluate how safe the device is and how easy it is for healthcare providers to use in patients receiving care in the Intensive Care Unit (ICU).
- Trial name
- NCT07806812
- Testing
- Sage Guard oral protection device
- Sponsor
- Wake Forest University Health Sciences
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
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
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
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.
Diffuse Large B Cell Lymphoma, Multiple Myeloma
Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia
Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy.
- Trial name
- PC002 (NCT06323447)
- Testing
- PointCheck
- Where
- 6 sites in United States, Spain
- Volunteers
- 210 people
- Sponsor
- Leuko Labs, Inc.
Cerebral Palsy, Acquired Brain Injury
Safety and Usability of a Robotic Gait Device for Children and Adolescents With Neurological or Neuromuscular Disease in Their Natural Environment
The goal of this clinical trial is to analyze the usability and safety of the robotic gait device EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.
- Conditions
- Cerebral Palsy, Acquired Brain Injury, Spinal Muscular Atrophy
- Trial name
- NCT06167954
- Testing
- EXPLORER
- Where
- 5 sites in Spain
- Volunteers
- 50 people
- Sponsor
- MarsiBionics
Cerebral Palsy, Spastic, Hemiplegia, Spastic
Changes in Motor and Cognitive Function on Unilateral Spastic Cerebral Palsy, Associated With Videogame Therapy
The use of interactive applications associated with position and movement sensors has begun to spread as an option for the reinforcement of physical rehabilitation therapies in patients with congenital or acquired motor disorders…
- Trial name
- NCT05557305
- Testing
- Videogame therapy, Conventional therapy
- Where
- Mexico
- Volunteers
- 84 people
- Sponsor
- Universidad Nacional Autonoma de Mexico
Heart Diseases
ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices
The registry is an international, multicenter, non-randomized, non-invasive study to assess the safety, performance and usability of the Occlutech Accessories "Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP)…
- Trial name
- NCT05174442
- Where
- 36 sites in Germany, Turkey (Türkiye)
- Volunteers
- 685 people
- Sponsor
- Occlutech International AB
Postdural Puncture Headache, Epidural Analgesia, Obstetric
A Prospective Cohort Study to Evaluate the Safety, Efficacy, and Usability of the EpiZact Device
The purpose of the study is to learn more about a new device, the EpiZact Epidural Device, that may be helpful for reducing the likelihood of wet tap when a labor epidural is placed.
- Trial name
- NCT06729255
- Testing
- EpiZact-assisted epidural placement
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Oregon Health and Science University