Wipro GE Healthcare Pvt. Ltd
Bangalore, Karnataka, 560066, India
NCT Number: NCT02946242
Ultrasound devices components and accessories are under continuous development in order to optimize, validate and improve the devices, including improving the quality of images. In this study, GEHC proposes to collect data in order to achieve the following
1. Aim 1: Perform iterative evaluations of the device (including features, accessories and components) to optimize device performance, assess feasibility of new features, and to perform testing necessary to support product and technology development; 2. Aim 2: Perform activities to support design validation and/or to confirm user requirements and specifications have been met, as per design controls and other applicable requirements; 3. Aim 3: Evaluate device complaints and analyze potential causes. There is no animal or phantom model that is adequate to accomplish these aims; therefore human subjects are required.
Due to the inherently varied nature of study data, specific data points will be recorded on a per-case basis and the study final report will summarize at minimum number and type of study scans conducted. Electronic image data may be collected. The number and type of safety issues, including adverse events (AEs) and serious adverse events (SAEs) will be reported. Unexpected device issues that occur outside of expected and controlled engineering optimization will be reported.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Bangalore, Karnataka, 560066, India
Subjects will be considered enrolled that provide written informed consent to participate, and with thereafter be scheduled to attend up to up to five (5) ultrasound scans per day lasting up to 60 cumulative minutes each with approximately a 15 minute break before starting another study scan (limited to 15 cumulative minutes of scan time per eye, per day for ophthalmic scanning) as long as they remain eligible per the study inclusion and eligibility criteria. Vital sign information about subjects may be collected and subjects will be positioned for scanning of a variety of target anatomic areas using a variety of non-invasive, transcutaneous techniques, such as scanning abdominal, musculoskeletal, breast(s), peripleural, transcranial, cervical/neck, cardiac, ophthalmic, vascular, extremity, soft tissue, and other accessible anatomical regions. The subject will be monitored for adverse events throughout the research study scan. The resultant images and associated data will be recorded and stored as part of study data.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be scheduled to attend up to up to five (5) ultrasound scans per day lasting up to 60 cumulative minutes each with approximately a 15 minute break before starting another study scan (limited to 15 cumulative minutes of scan time per eye, per day for ophthalmic scanning) as long as they remain eligible per the study inclusion and eligibility criteria.
Time frame: 1 day
Parameters, features, and operator notes from the exam will be recorded to support diagnostic exam completion
Time frame: 1 day
GE Healthcare
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06978374
Axial Spondylarthritis (axSpA), Muscular Diseases
Ankara, Mamak, Turkey (Türkiye)
View Trial DetailsNCT06744192
Acetabular Labrum Tear, Diagnostic Imaging
Beijing, Beijing Municipality, China
View Trial DetailsNCT06780436
3D SONOGRAPHY, Brain Diseases
Fort Sam Houston, Texas, United States
View Trial DetailsNCT06882928
Arthritis, Fall Risk
Taipei, Taiwan
View Trial Details