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NCT03257839 · ClinicalTrials.gov registry record
Delphinus SoftVue Prospective Case Collection - ARM 1
A clinical trial, sponsored by Delphinus Medical Technologies.
- Completed
- Registry status
- 7,409
- Enrollment target
NCT03257839: Completed study, sponsored by Delphinus Medical Technologies.
NCT03257839 is a clinical trial that has completed, run by Delphinus Medical Technologies. The registered enrollment target is 7,409 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03257839 has completed, sponsored by Delphinus Medical Technologies.
- COMPLETED
- Registry status
- 7,409 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 1 aims to collectively enroll up to 17,500 women at a total of up to 8 clinical sites. The design of this protocol is strictly limited to case collection; all investigational and statistical plans for future analyses will be prepared and registered separately, if they are applicable to the requirements of FDAAA 801. Arm 1 is limited to the
Primary Outcome
Non-Cancer cases, confirmed by normal or negative mammographic breast imaging (FFDM or DBT), or breast biopsy with benign pathology, after at least 365 days of follow-up
Interventions
- DEVICE Automated Whole Breast Ultrasound
- DEVICE Routine Full-Field Digital Mammography
- DEVICE Routine Digital Breast Tomosynthesis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,409 participants |
| Start Date | 2017-07-31 |
| Est. Completion | 2021-07-31 |
What the finished NCT03257839 record still lists
NCT03257839 is an observational study that tracks outcomes without assigning an intervention. Its 7,409 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 3 interventions - of which Automated Whole Breast Ultrasound is the first listed.
NCT03257839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03257839 about?
NCT03257839 is a clinical study titled "Delphinus SoftVue Prospective Case Collection - ARM 1". 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 NCT03257839?
This trial is currently completed. The enrollment target is 7,409 participants. The study started on 2017-07-31. Estimated completion is 2021-07-31.
What interventions are being tested in trial NCT03257839?
The interventions under investigation include: Automated Whole Breast Ultrasound (DEVICE), Routine Full-Field Digital Mammography (DEVICE), Routine Digital Breast Tomosynthesis (DEVICE).
Who is sponsoring clinical trial NCT03257839?
This trial is sponsored by Delphinus Medical Technologies, which has 5 total clinical trials registered on ClinicalTrials.gov.
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