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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
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Ultrasound Exam | Other | Each subject may elect to participate in up to five (5) study scans per day lasting up to 60 cumulative minutes each with approximately a 15 minute break before starting another study scan. Ophthalmic scanning will be limited to no more than 15 cumulative minutes of scan time per eye, per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Exam | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of diagnostic ultrasound exam | Parameters, features, and operator notes from the exam will be recorded to support diagnostic exam completion | 1 day |
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| Measure | Description | Time Frame |
|---|---|---|
| Exam completion data may be stratified by exam type/indication based on actual site accrual. | 1 day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhumita Gupta, MD | GE Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wipro GE Healthcare Pvt. Ltd | Bangalore | Karnataka | 560066 | India |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2018 | Jul 18, 2022 | Prot_000.pdf |
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