CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 480 enrolled
Drug / intervention
Reader Study - Imagio Ultrasound +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04030104
NCT04030104N/ACompleted
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Imagio® Pivotal Multi-Reader, Multi-Case Study of Optoacoustic Images Versus Imagio® Ultrasound to Guide Decision to Biopsy

Seno Medical Instruments Inc.·interventional·Posted Jul 23, 2019·Updated Jul 12, 2021

In Brief

A clinical study evaluating Reader Study - Imagio Ultrasound, Reader Study Imagio Ultrasound + Optoacoustic Imaging, and 1 other intervention for Breast Cancer. Completed, enrolled 480 participants across 1 site.

Detailed Summary

The Imagio® Pivotal Study is intended to evaluate if the results observed in the previous Feasibility Study can be confirmed for pre-specified effectiveness endpoints. Using Intention-to-Diagnose (ITD) masses from the PIONEER Pivotal study, 480 to 840 masses are to be used for the Pivotal Study, the remaining masses will be reserved for training the SenoGram® model.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 23, 2019
Enrollment StartJul 30, 2019
Primary CompletionNov 3, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.9 years ago

Interventions

Reader Study - Imagio Ultrasounddevice

Imagio ultrasound images to be reviewed as part of Reader study

Reader Study Imagio Ultrasound + Optoacoustic Imagingdevice

Imagio Ultrasound + Optoacoustic images to be reviewed as part of Reader study

Mammographydevice

Mammography as available per standard of care