Clinical trials: Device Usability
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
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
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
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
Wrinkle, Acne Scars
Post Market Usability Evaluation Of The PicoSure Pro Device
The intended use of the PicoSure and PicoSure Pro devices used in this study is to treat additional patients with the new PicoSure Pro device and collect additional data on the devices.
- Conditions
- Wrinkle, Acne Scars, Benign Epidermal Pigmented Lesions, Benign Dermal Pigmented Lesions
- Trial name
- NCT05102617
- Testing
- PicoSure Pro Device, PicoSure Device, Topical Cosmeceuticals
- Where
- 2 sites in United States
- Volunteers
- 23 people
- Sponsor
- Cynosure, Inc.
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
to Aid in Sperm Selection for ICSI
User Site Testing Study to Evaluate Usability of the Q300™ Device Under "Real-life Conditions" in a Reproductive Laboratory Environment Use
User Site Testing Study to evaluate usability of the Q300™ device under "real-life conditions" in a reproductive laboratory environment use.
- Trial name
- NCT06232720
- Testing
- Q300 QART Medical
- Where
- Israel
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- QART Medical
Usability
Non-Contact Monitoring of Subjects With an Optical Device: A Pilot Usability Study
This is a single-center, prospective study in subjects visiting TASMC for various indications. This study will be divided into two arms: First Arm - Subjects measured by the study staff via the investigational device at the…
- Trial name
- NCT04182165
- Testing
- Gili BioSensor System/ Gili Pro X BioSensor System
- Where
- Israel
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- ContinUse Biometrics Ltd.
Infant Nutrition Disorders, Weight Loss
Feasibility and Validation of a Smart Changing Pad for Home Infant Weight Monitoring After Hospital Discharge
This pilot study evaluates the feasibility, usability, and clinical utility of the Woddle Smart Changing Pad and companion mobile application for infant monitoring following hospital or NICU discharge.
- Conditions
- Infant Nutrition Disorders, Weight Loss, Postnatal Care, Premature Birth
- Trial name
- NCT07718516
- Testing
- Woddle Smart Changing Pad
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Stan Kachnowski
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
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.
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.
Obstructive Sleep Apnea
PAP-NAP Device Clinical Study
This exploratory pilot study will evaluate the usability and short-term tolerability of a novel positive airway pressure (PAP) device in adults during a supervised daytime nap session in a simulated sleep environment.
- Trial name
- NCT07785310
- Testing
- APL Device
- Volunteers
- 10 people
- Sponsor
- ResMed
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.
Sleep Disorder
Evaluation of the Usability and Performance Assessment of the DormoTech VLAB Device as a Home Sleep Test
The study is a comparative, self-controlled, randomized, prospective investigation designed to assess the usability and accuracy of the DormoTech Vlab and compare its performance with a full polysomnography (PSG) study conducted…
- Trial name
- NCT06224972
- Testing
- Vlab
- Where
- Israel
- Volunteers
- 47 people
- Sponsor
- Dormotech Medical
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
Onychomycosis of Toenail
Light Therapy for Onychomycosis Study
This is a pilot prospective study designed to capture information about the safety and effectiveness of the ToeFX Therapy Light.
- Trial name
- NCT05139888
- Testing
- Single wavelength light (red) only, Dual wavelength light (red/blue)
- Where
- Canada
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- ToeFX Inc.
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
Cataract Surgery
Pilot Study: Feasibility and Usability of a Head-Mounted Spatial Computing Device for Intraoperative Visualization During Intraocular Surgery
To evaluate the feasibility and usability of Apple Vision Pro as an adjunct visualization and information display tool during ophthalmic surgery.
- Trial name
- NCT07825337
- Testing
- Apple Vision Pro Visualization System
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Eric Rosenberg