Imagio Feasibility Multi-Reader, Multi-Case Study

Status Completed

Clinical Trial Summary

Controlled, blinded, multi-reader, multi-case study

Clinical Trial Description

The Imagio Feasibility Reader Study-01 Study is intended to evaluate if a subsequent pivotal study can be implemented to test prospective hypotheses for pre-specified effectiveness endpoints with an acceptable sample size. The Feasibility Study will be based on ITD masses from the PIONEER (NCT01943916) Pivotal study to simultaneously reflect the distributions with and without mammograms as well as site CDU BI-RADS scores within benign and malignant masses as strata. The study population will be split into 3 cohorts - Cohort 1, the 120 patient ITD Population used to run the primary/ secondary analyses. Cohort 2, 30 patients used to run exploratory analyses on false negative rate and Cohort 3, 5 patients used to run exploratory analyses on specific mass types ;

Study Design

Related Conditions & MeSH terms

Breast Cancer

Clinical Trial Details

NCT number	NCT03708393
Study type	Interventional
Source	Seno Medical Instruments Inc.
Contact
Status	Completed
Phase	N/A
Start date	November 13, 2018
Completion date	December 9, 2018

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