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NCT02977247 · ClinicalTrials.gov registry record
Delphinus SoftVue Prospective Case Collection - ARM 2
A clinical trial, sponsored by Delphinus Medical Technologies.
- Completed
- Registry status
- 1,150
- Enrollment target
NCT02977247 is a clinical trial that has completed, run by Delphinus Medical Technologies. The registered enrollment target is 1,150 participants.
The verdict
NCT02977247 has completed, sponsored by Delphinus Medical Technologies.
- COMPLETED
- Registry status
- 1,150 participants
- Enrollment target
Study Summary
The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B-mode ultrasonic breast imaging system and color imaging of transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a replacement for screening mammography. SoftVue uses non-ionizing ultrasound energy to generate tomographic image volumes of the whole breast. While the patient lays prone on a padded table with one breast comfortably submerged in a bath of warm water, a ring-shaped transducer, 22 cm in diameter, encircles the breast and pulses low-frequency sound waves through the water and into the breast tissue. More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive ultrasound signals to analyze echoes from the breast anatomy in all directions, from the chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound waves off of tissue boundaries and structures within the breast, but because the transducer surrounds the whole breast, SoftVue also captures signals that are transmitted through the breast. This additional transmission data enhances the visualization of the anatomic structure of the breast tissue and is not currently available in any other commercially marketed breast ultrasound device. This prospective, multicenter, multi-arm, clinical case collection program is IRB-approved and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki and all applicable regulatory requirements. Arm 2 aims to collectively enroll up to 1,000 women at a total of up to 8 clinical sites. The design of Arm 2 in this protocol is strictly limited to case collection and is non-interventional; any investigational and/or statistical plans for future analyses will be prepared and registered separately, if they are applicable to the requirements of
Interventions
- OTHER Non-Interventional
- DEVICE Automated Whole Breast Ultrasound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,150 participants |
| Start Date | 2016-12-06 |
| Est. Completion | 2021-07-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02977247
The ClinicalTrials.gov registry entry for NCT02977247 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Delphinus Medical Technologies, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Non-Interventional is the first listed.
NCT02977247 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02977247 about?
NCT02977247 is a clinical study titled "Delphinus SoftVue Prospective Case Collection - ARM 2". The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B-mode ultrasonic breast imaging system and color imaging of transmission data (sound speed a...
What is the current status of trial NCT02977247?
This trial is currently completed. The enrollment target is 1,150 participants. The study started on 2016-12-06. Estimated completion is 2021-07-31.
What interventions are being tested in trial NCT02977247?
The interventions under investigation include: Non-Interventional (OTHER), Automated Whole Breast Ultrasound (DEVICE).
Who is sponsoring clinical trial NCT02977247?
This trial is sponsored by Delphinus Medical Technologies, which has 5 total clinical trials registered on ClinicalTrials.gov.
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