Development Of Medical Ultrasound Systems, Accessories, And Components - GE Bangalore

NCT ID: NCT02946242

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-29
• Study Completion Date: 2021-12-17

Brief Summary

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.

Detailed Description

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.

Conditions

Ultrasound Exams

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

General Ultrasound Exam

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.

Group Type: OTHER

Ultrasound Exam

Intervention Type: 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.

Interventions

Ultrasound Exam

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Aged 18 years or older

2. Able and willing to provide written informed consent in accordance with the PNDT Act in India

3. Able to understand and respond in English

4. General Electric (GE) employee or contractor at the John F. Welch Technology Centre (JFWTC) facility.

Exclusion Criteria

1. Direct employee or contractor of the General Electric (GE) Ultrasound business at the John F. Welch Technology Centre (JFWTC) facility

2. If female, pregnant or unsure of her pregnancy status per self-report.

3. Is not able to or would be put at additional risk from completing study activities, in the opinion of the study staff.

4. Subjects who have an electronic medical device at the time of the study scan (such as pacemaker, implantable cardioverter/defibrillator, insulin pump, cochlear implant, or other implanted electronic medical device).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Madhumita Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

GE Healthcare

Locations

Wipro GE Healthcare Pvt. Ltd

Bangalore, Karnataka, India

Countries

India

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

110.08-2015-GES-0004

Identifier Type: -

Identifier Source: org_study_id