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

NCT02946242 | Completed

• 1 other identifier: 110.08-2015-GES-0004
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Ultrasound Exams

Outcome Measures

Primary Outcomes (1)

• Completion of diagnostic ultrasound exam

  Parameters, features, and operator notes from the exam will be recorded to support diagnostic exam completion

  1 day

Other Outcomes (1)

• Exam completion data may be stratified by exam type/indication based on actual site accrual.

  1 day

Study Arms (1)

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.

Device: Ultrasound Exam

Interventions

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.

General Ultrasound Exam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Able and willing to provide written informed consent in accordance with the PNDT Act in India
• Able to understand and respond in English
• General Electric (GE) employee or contractor at the John F. Welch Technology Centre (JFWTC) facility.

You may not qualify if:

• Direct employee or contractor of the General Electric (GE) Ultrasound business at the John F. Welch Technology Centre (JFWTC) facility
• If female, pregnant or unsure of her pregnancy status per self-report.
• Is not able to or would be put at additional risk from completing study activities, in the opinion of the study staff.
• 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).

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Wipro GE Healthcare Pvt. Ltd

Bangalore, Karnataka, 560066, India

Location

Study Officials

• Madhumita Gupta, MD

  GE Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 27, 2016
• Study Start: November 29, 2016
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: May 1, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)