Clinical trials: Safety and Usability
Apoplexy; Stroke, Spinal Cord Injuries
Clinical Trial ROBERT® - Project Active Training
The overall purpose with this clinical trial is to, monitor and secure ROBERT®'s clinical performance and safety in a clinical environment in the regional hospital North Denmark, Neuro Unit North.
- Conditions
- Apoplexy; Stroke, Spinal Cord Injuries, Safety, Usability
- Trial name
- NCT04304976
- Testing
- ROBERT®
- Where
- Denmark
- Volunteers
- 8 people
- Sponsor
- Lifescience-Robotics
Respiratory Failure
Safety and Usability of the LUMENA Non-invasive Ventilation Mask
Evaluation of the safety and efficacy of using the Lumena mask, compared to commercially-available, commonly used Oro-nasal masks.
- Trial name
- NCT05479773
- Testing
- Standard NIV mask, Lumena NIV mask
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Inspir Labs Ltd.
Stroke, Parkinson Disease
PhiCube for Bilateral Upper Limb Neuromotor and Cognitive Rehabilitation in Adults
This randomized controlled pilot trial evaluates the usability and safety of PhiCube, a compact, portable, bilateral end-effector robotic device for upper limb rehabilitation, and its impact on motor and cognitive function.
- Conditions
- Stroke, Parkinson Disease, Amyotrophic Lateral Sclerosis, Spinal Cord Injuries
- Trial name
- PhiCube-Adults (NCT07865260)
- Testing
- PhiCube, Conventional rehabilitation
- Where
- 4 sites in Italy
- Volunteers
- 80 people
- Sponsor
- Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
Stroke, Healthy
Study to Evaluate Performance, Usability, Safety of Microwave Technology When Collecting Data From Patients With Stroke
This is a prospective, open, multicenter study that will enroll patients admitted to and hospitalized at the Stroke Unit due to diagnosed stroke and healthy volunteers.
- Trial name
- NCT02266459
- Testing
- Microwave technology (Medfield Diagnostics)
- Where
- 3 sites in Sweden
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- Medfield Diagnostics
Rheumatoid Arthritis
An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis
A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects with Rheumatoid Arthritis.
- Trial name
- NCT03193957
- Testing
- Etanercept, Autoinjector
- Where
- Poland
- Volunteers
- 50 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Needle Stick Injuries
A Single-institutional Study to Assess the Time Efficiency and Working Satisfaction Using ANDY(Automatic Needle Destroyer)
Evaluate the efficiency of adopting the automated needle processing system by evaluating efficiency, usability and safety when using ANDY(Automatic Needle Destroyer).
- Trial name
- NCT04039906
- Testing
- Removal of needle with using ANDYs
- Where
- South Korea
- Volunteers
- 129 people
- Sponsor
- Samsung Medical Center
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
Incontinence, Urge
T-DOC® NXT Clinical Investigation
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
- Trial name
- NCT03615001
- Testing
- TDOC NXT
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
Hemostasis, Distal Radial Artery Access (dTRA)
Evaluation of Safety, Performance and Usability of the TR Band DISTAL Device for Hemostasis Following Distal Radial Access in Coronary Procedures
This clinical study has been organised to learn more about the safety and use of the TR Band Distal device in patients who have had a heart procedure through a blood vessel in the wrist near the base of the thumb (called distal…
- Trial name
- EASY DISTAL (NCT07888738)
- Testing
- TR Band Distal
- Where
- 7 sites in Austria, Belgium and 2 more
- Volunteers
- 320 people
- Sponsor
- Terumo Europe N.V.
Multiple Sclerosis, Vestibular Disease
Conventional Vestibular Training Versus Immersive Virtual Reality- Based Vestibular in Multiple Sclerosis
The effectiveness of convectional vestibular training for balance and dizziness rehabilitation in people with multiple sclerosis has been recently demonstrated in a meta-analysis by this research team (doi: 10.3390/jcm9020590).
- Conditions
- Multiple Sclerosis, Vestibular Disease, Dizziness, Balance Disorders
- Trial name
- NCT04497025
- Testing
- Immersive Virtual-based vestibular rehabilitation, Conventional vestibular rehabilitation protocol
- Where
- Spain
- Sponsor
- Maria Jesus Casuso-Holgado
Healthy
Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device
This project is being completed to test the usability and safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device.
- Trial name
- NCT06366074
- Testing
- Watch-TEA group, Tethered TEA device
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Michigan
Chronic Kidney Disease Stage 5
A Single Arm, Multi-Center Study To Evaluate The Intelligent Dialysis Assistant (IDA)
This is a multi-center, open label, cross-over clinical study. A total of 18 subjects will be enrolled to use the IDA for every peritoneal dialysis exchange for 14 days.
- Trial name
- NCT04808011
- Testing
- Intelligent Dialysis Assistant (IDA)
- Where
- 3 sites in Israel
- Volunteers
- 20 people
- Sponsor
- liberDi Ltd.
Induction of Labor, Cervical Ripening
Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP)
The goal of this clinical study is to evaluate a new mechanical balloon catheter (INGA) used to prepare the cervix for labor induction in pregnant women at term.
- Conditions
- Induction of Labor, Cervical Ripening, Cervical Ripening and Induction of Labor
- Trial name
- INGA-MDP (NCT07414771)
- Testing
- Cervical ripening, labor induction
- Where
- 3 sites in Finland
- Volunteers
- 42 people
- Sponsor
- Aalto University
Brain Tumor Adult, Epilepsy
WISE Cortical Strip for Intraoperative Neurophysiological Monitoring
The WIN Study is a prospective, interventional, multi-center, open-label premarket study designed to confirm the safety, performance and intended use of the WISE Cortical Strip (WCS) for CE certification purposes.
- Trial name
- WIN (NCT03731455)
- Testing
- WISE Cortical Strip
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 32 people
- Sponsor
- Wise S.r.l.
Glaucoma
A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma
This is a prospective, multi-center, international, cohort expansion study. Part 1 will be conducted in subjects with open angle glaucoma to identify the best insertion tool for MINIject S+.
- Trial name
- STAR VII (NCT07009236)
- Testing
- MIGS
- Where
- 5 sites in Honduras, United Kingdom
- Volunteers
- 60 people
- Sponsor
- iSTAR Medical
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
Chronic Kidney Disease Stage V
A Prospective, Open-label, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA
This is a multi-center, open label, cross-over clinical study. A total of 15 subjects will be enrolled to use the IDA for every peritoneal dialysis exchange for 14 days.
- Trial name
- CSP-027-21 (NCT05342935)
- Testing
- Inteligent Dialysis Assistant (IDA)
- Volunteers
- 15 people
- Sponsor
- liberDi Ltd.
Safety, Acceptability
MATRIX-002: Trial to Assess Acceptability and Safety of Two Placebo Vaginal Films
This study will enroll approximately 100 HIV-negative persons, aged18-45 years, and assigned female sex at birth from sites in the United States, Kenya, South Africa, and Zimbabwe.
- Conditions
- Safety, Acceptability, Usability
- Trial name
- NCT06046053
- Where
- 5 sites in United States, Kenya and 2 more
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Rohan, Lisa, PhD
Urodynamics
e۰Sense® Catheter Clinical Investigation
This pre-market study will be conducted on consenting patients undergoing a medically prescribed, invasive, conventional urodynamics (UDS) test using the investigational device (e۰Sense® urodynamic catheters).
- Trial name
- NCT04438499
- Testing
- eSense 7fr Single Sensor Bladder Catheter
- Where
- 2 sites in France, Germany
- Volunteers
- 61 people
- Sponsor
- Laborie Medical Technologies Inc.