Clinical trials: Device Usability
RA
To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis
Primary Objective: To collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid arthritis (RA) participants.
- Trial name
- SARIL-RA-EASY (NCT02057250)
- Testing
- Sarilumab, Auto-Injector Device (AID), Pre-filled Syringe (PFS)
- Where
- 53 sites in United States, Chile and 4 more
- Volunteers
- 217 people
- Sponsor
- Sanofi
Physician Feedback
Laparoscopic Measuring Device Study
This study is gathering opinions from surgeons on the usability of our laparoscopic measuring device.
- Trial name
- LMD-1 (NCT03234855)
- Testing
- LMD
- Where
- 3 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Boehringer Labs LLC
Neoplasms, Neutropenia
PC001- A Study to Evaluate the Usability of PointCheck
This a study about the usability of PointCheck a novel non-invasive technology for monitoring chemotherapy-induced neutropenia. The study will include patients with cancer visiting the outpatient hematology clinic for their…
- Trial name
- NCT04448301
- Testing
- PointCheck
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- Leuko Labs, Inc.
Blindness and Low Vision
A Pilot Study Comparing Performance of Blind Participants on 12 Tasks, With and Without the ARIA Device
Summary The environment in which we live, play and travel is primarily built by and for people with sight. Navigating the sighted world with blindness can be exhausting, as it involves disorientation, social isolation, increased…
- Trial name
- NCT06477809
- Testing
- ARIA Glasses ( Augmented Reality in Audio )
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- ARIA Research Pty Ltd
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
Colon Neoplasms, Crohn Disease (CD)
Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery
This is a first-in-human feasibility study designed to evaluate the safety and performance of the SEGER device in patients undergoing elective laparoscopic gastrointestinal surgery requiring intracorporeal anastomosis.
- Conditions
- Colon Neoplasms, Crohn Disease (CD), Obesity & Overweight
- Trial name
- SEGER-FIH (NCT07508592)
- Testing
- SEGER Device
- Where
- El Salvador
- Volunteers
- 10 people
- Sponsor
- Seger Surgical Solutions
COVID-19 Virus Infection, COVID-19
Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC
A rapid point of care test for the detection of virus particles will be compared to the FDA approved EUA RT-PCR detection standard.
- Conditions
- COVID-19 Virus Infection, COVID-19, Coronavirus Disease-19, COVID-19 Pandemic
- Trial name
- NCT05514691
- Testing
- iStatis COVID-19 Ag Rapid Test, "COVID-19 RT-PCR Test EUA Number: EUA200011, Company: Laboratory Corporation of America ("Labcorp")
- Where
- 2 sites in United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Perineal Trauma
Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
This is a single-center, prospective, non-randomized post-market clinical follow-up study evaluating the implementation and clinical performance of ASISU during routine vaginal childbirth.
- Trial name
- ASISU-PMCF (NCT07844005)
- Testing
- Perineal protection device
- Where
- Denmark
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- oasicare ApS
Substance Abuse
Accuracy & Usability Study for Soberlink Cellular Device
This study scope is to validate the accuracy and usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro.
- Trial name
- NCT02794038
- Testing
- Soberlink Cellular Device, BACtrack S80 Pro
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Soberlink Healthcare LLC
Usability
Summative Usability Study of CEREBO® - a Non Invasive Intracranial Hemorrhage Detector
Traumatic brain injury is one of the most common reasons for visits to the Emergency Department. More than 90% of patients who have suffered from head trauma present with a mild traumatic brain injury.
- Trial name
- NCT05340127
- Testing
- CEREBO®
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Bioscan Research Pvt. Ltd.
Relapsing Remitting Multiple Sclerosis
Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple Sclerosis
The main purpose of this study is to assess the usability and value of the multiple sclerosis (MS) care management platform in terms of improved monitoring of people with MS (pwMS) in clinical practice.
- Trial name
- ILLUMINATE (NCT05949580)
- Testing
- MS Care Platform (icobrain ms and icompanion ms)
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
Feeding Tube, Dysphagia
Safety and Usability Evaluation of the Fidmi Low-Profile Enteral Feeding Device
A First In Human Usability Open Label trial will be performed using the Fidmi Feeding device on 20 adult patients with a need for enteral feeding.
- Trial name
- Fidmi (NCT03007511)
- Testing
- Fidmi enhanced enteral feeding device
- Where
- 2 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Fidmi Medical
Stroke, Gait, Hemiplegic
Evaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke
This study aims to evaluate the safety and usability of a motorized mobility assistance exoskeleton (MAK). The procedure explores the use of the MAK exoskeleton during the static and dynamic rehabilitation sessions with the…
- Trial name
- NCT04837144
- Testing
- Physical Rehabilitation with MAK exoskeleton
- Where
- Spain
- Volunteers
- 6 people
- Sponsor
- MarsiBionics
IUD Insertion
Usability, Safety and Efficacy of AspivixTM
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
- NCT04441333
- Testing
- AspivixTM cervical vacuum tenaculum
- Where
- Switzerland
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Aspivix SA
Obstructive Sleep Apnea
Simulated In-House Usability Study of Eclipse Continuous Positive Airway Pressure (CPAP) Device
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd…
- Trial name
- NCT05570747
- Testing
- Usability
- Where
- 3 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Hypercholesterolaemia
Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
Primary Objective: To collect real-use (usability) data assessing the robustness and user interaction of the new alirocumab auto-injector device (which is referred to as SYDNEY), in unsupervised settings.
- Trial name
- NCT03415178
- Testing
- Alirocumab SAR236553, Current auto-injector device (AI), New auto-injector device (SYDNEY)
- Where
- 13 sites in United States
- Volunteers
- 69 people
- Sponsor
- Sanofi
Pressure Ulcer, Pressure Injury
Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection
This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.
- Conditions
- Pressure Ulcer, Pressure Injury, Falls Injury
- Trial name
- NCT03121144
- Testing
- Masimo Centroid System
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Masimo Corporation
Respiratory Infection Virus, COVID-19
Noseguard for Prevention of Respiratory Infections in Real-World Use
This study is a prospective clinical study to evaluate the effectiveness of combined use of two nasal protective medical devices (Noseguard and Noseguard Night) in reducing respiratory infection rates, including COVID-19 and…
- Conditions
- Respiratory Infection Virus, COVID-19, Influenza
- Trial name
- NCT07516977
- Testing
- Noseguard and Noseguard Night
- Where
- South Korea
- Volunteers
- 2,000 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Venous Disease, Quality of Life
Blinded Consumer Study for the Evaluation of the Usability and Efficacy of One Medical Device in Venous Return
The primary goal of this study was to assess, in vivo, the efficacy of the medical device Invisible insoles LIGHT LEGS in improving venous return in subjects affected by this problem after 14 days of medical device use, by…
- Conditions
- Venous Disease, Quality of Life, Symptoms and Signs
- Trial name
- NCT07234240
- Testing
- Insoles
- Where
- Portugal
- Volunteers
- 54 people
- Sponsor
- Millet Innovation
Overactive Bladder
Clinical Trial for the Assessment of Safety, Usability and Efficacy of the Vixe Combination for OAB in Female Subjects
The goal of this interventional clinical trial is to assess the safety, usability and initial efficacy of Xeomin and Vibe combination (ViXe) compared to placebo + sham in female subjects with idiopathic Overactive Bladder.
- Trial name
- XAVIER (NCT06345677)
- Testing
- ViXe Xombination
- Where
- 8 sites in Portugal
- Volunteers
- 48 people
- Sponsor
- Vensica Therapeutics Ltd.