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NCT02946242
Development Of Medical Ultrasound Systems, Accessories, And Components - GE Bangalore
NA trial testing Ultrasound Exam in Ultrasound Exams in 39 participants. Completed in 17 December 2021.
17 December 2021
Quick facts
| Lead sponsor | GE Healthcare |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 39 |
| Start date | 29 November 2016 |
| Primary completion | 17 December 2021 |
| Estimated completion | 17 December 2021 |
| Sites | 1 location across India |
Drugs / interventions tested
- Ultrasound Exam
Conditions studied
- Ultrasound Exams — all drugs for Ultrasound Exams →
Sponsor
GE Healthcare — full company profile →
Who can join
18 and older, any sex, with Ultrasound Exams. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02946242
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02946242 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GE Healthcare
- Last refreshed: 1 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02946242.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing